Recall Register

Siemens Medical Solutions USA, Inc: FDA recalls

FDA enforcement reports name Siemens Medical Solutions USA, Inc as the recalling firm in 400 events. The events have 796 product records. The recalls started from 2011 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

400 events, newest first.

FDA enforcement events of Siemens Medical Solutions USA, Inc
InitiatedProduct (first record)TypeClassRecordsStatus
8 Jun 2026ARTIS icono ceiling. Model Number: 11328100.DeviceClass II1Ongoing
20 May 2026ARTIS icono biplane. Model Number: 11327600.DeviceClass II3Ongoing
12 Mar 2026ARTIS Pheno VE30A and VE40A, Model 10849000DeviceClass II1Ongoing
10 Mar 2026ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.DeviceClass II1Ongoing
9 Mar 2026ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray systemDeviceClass II2Ongoing
29 Dec 2025Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02DeviceClass II2Ongoing
19 Dec 2025SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTSDeviceClass II4Ongoing
5 Dec 2025LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471DeviceClass II1Ongoing
24 Oct 2025MAMMOMAT Revelation;DeviceClass II3Ongoing
1 Oct 2025MAGNETOM Cima.X Upgrade. Model Number: 11689304.DeviceClass I1Ongoing
28 Aug 2025Biograph mMR. Model Number: 10433372.DeviceClass I15Ongoing
12 Aug 2025Artis Pheno. Image-Intensified Flouroscopic X-Ray System.DeviceClass II1Ongoing
4 Jun 2025UROSKOP Omnia. Model Number: 10094910DeviceClass II2Ongoing
15 May 2025ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography,…DeviceClass II4Ongoing
2 Jan 2025ARTIS One Angiographic X-Ray SystemDeviceClass II1Ongoing
15 Aug 2024ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.DeviceClass II3Ongoing
3 Jul 2024Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by…DeviceClass II4Ongoing
2 Jul 2024Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472DeviceClass II4Ongoing
31 May 2024AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399DeviceClass II9Ongoing
21 Mar 2024Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis…DeviceClass II1Ongoing
23 Feb 2024ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30CDeviceClass II3Ongoing
29 Nov 2023Sensis Vibe HemoDeviceClass II1Ongoing
17 Oct 2023ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100DeviceClass II1Ongoing
5 Oct 2023Mobilett Mira wireless (VA20) mobile x-ray system(s)DeviceClass II1Ongoing
12 Sep 2023Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200DeviceClass II2Ongoing
1 Sep 2023(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 11408424 & 11408425; MAGNETOM Free.Star 11408426…DeviceClass II1Ongoing
13 Jul 2023ACUSON Redwood 2.0 ultrasound systems, REF: 11503314DeviceClass II1Ongoing
12 Jul 2023The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.DeviceClass II1Ongoing
19 Jun 2023ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600DeviceClass II3Ongoing
5 Jun 2023Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088DeviceClass II1Ongoing
21 Mar 2023ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600DeviceClass II1Ongoing
2 Feb 2023ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.DeviceClass II1Ongoing
2 Feb 2023ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000DeviceClass II1Ongoing
16 Jan 2023SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, EmissionDeviceClass II3Ongoing
22 Dec 2022Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All…DeviceClass II1Ongoing
21 Dec 2022Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200DeviceClass II5Ongoing
16 Dec 2022System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen…DeviceClass II1Ongoing
16 Dec 2022ARTIS pheno, ARTIS icono biplane, and ARTIS icono floorDeviceClass II1Ongoing
9 Dec 2022AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRFDeviceClass II3Ongoing
23 Nov 2022Luminos Agile Max (VE10, VF10, VF11)DeviceClass II3Ongoing
16 Nov 2022Programmable Diagnostic ComputerDeviceClass II1Ongoing
9 Nov 2022ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.DeviceClass II1Ongoing
20 Sep 2022ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000DeviceClass II1Ongoing
10 Aug 2022Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355DeviceClass II3Ongoing
12 Jul 2022AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and…DeviceClass III1Terminated
15 Jun 2022Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561DeviceClass II2Ongoing
10 Jun 2022Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000DeviceClass II1Ongoing
24 May 2022Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray SystemDeviceClass II1Terminated
20 May 2022Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600DeviceClass II1Ongoing
13 Apr 2022Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620DeviceClass II1Ongoing
11 Apr 2022Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600DeviceClass II2Ongoing
11 Mar 2022Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT SystemsDeviceClass II1Terminated
7 Mar 2022syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.DeviceClass II4Terminated
7 Mar 2022Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,DeviceClass II1Ongoing
7 Mar 2022YSIO X.PreeDeviceClass II1Ongoing
7 Mar 2022SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed…DeviceClass II1Ongoing
25 Feb 2022syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700DeviceClass II1Ongoing
25 Feb 2022Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600DeviceClass II3Ongoing
23 Feb 2022Artis zee floor, Model Number 10094135DeviceClass II14Ongoing
31 Jan 2022Ysiosystem with VC10 software version, Model Number 10281013. Radiographic systemDeviceClass II1Ongoing
19 Jan 2022Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological…DeviceClass II1Ongoing
9 Dec 2021ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815DeviceClass II1Terminated
23 Nov 20211. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies,…DeviceClass II1Ongoing
19 Nov 2021SOMATOM Confidence -Computed tomography systems Model 10590100DeviceClass II4Ongoing
12 Nov 2021ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/BDeviceClass II1Ongoing
20 Oct 2021Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135DeviceClass II10Terminated
12 Oct 2021Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000DeviceClass II3Terminated
5 Oct 2021Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studiesDeviceClass II1Ongoing
24 Sep 2021Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815DeviceClass II1Ongoing
30 Aug 2021SOMATOM Force with software syngo.CT VB20 Model #10742326DeviceClass II7Terminated
18 Aug 2021Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed…DeviceClass II1Ongoing
16 Aug 2021syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180DeviceClass II3Ongoing
12 Jul 2021ACUSON Juniper Diagnostic Ultrasound SystemDeviceClass II1Terminated
30 Jun 2021Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for…DeviceClass II1Terminated
27 May 2021ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000DeviceClass II1Ongoing
20 Apr 2021Multitom RAX with software version VF10DeviceClass II1Terminated
30 Mar 2021Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis…DeviceClass II1Terminated
26 Mar 2021Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137DeviceClass II1Ongoing
19 Mar 2021Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
10 Mar 2021Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.DeviceClass II1Terminated
4 Mar 2021Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data…DeviceClass II1Terminated
3 Mar 2021Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model…DeviceClass II1Terminated
26 Feb 2021Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
4 Feb 2021Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound SystemsDeviceClass II1Ongoing
27 Jan 2021Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161…DeviceClass II1Terminated
18 Dec 2020ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.DeviceClass II1Terminated
30 Nov 2020Artis zee/ zeego & Artis Q/ Q.zen Artis PhenoDeviceClass II1Ongoing
24 Nov 2020SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge PlusDeviceClass II1Terminated
21 Oct 2020Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including,…DeviceClass II1Terminated
21 Sep 2020Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for…DeviceClass II1Terminated
18 Sep 2020ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
9 Sep 2020Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).DeviceClass II2Terminated
19 Aug 2020Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180DeviceClass II1Terminated
14 Aug 2020Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.DeviceClass II1Terminated
3 Aug 2020Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354…DeviceClass II1Terminated
30 Jul 2020Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.DeviceClass II2Terminated
24 Jul 2020Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.DeviceClass II1Terminated
14 Jul 2020Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applicationsDeviceClass II1Terminated
24 Jun 2020syngo.via RT Image Suite with software versions syngo.via VB30 or VB40DeviceClass II1Terminated
22 Jun 2020Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus…DeviceClass II1Terminated
22 May 2020ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5FDeviceClass II1Terminated
7 May 2020MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.DeviceClass II1Terminated
30 Apr 2020Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 Product Usage: Artis is a family of dedicated…DeviceClass II1Terminated
23 Apr 2020ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600DeviceClass II1Terminated
22 Apr 2020ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
20 Apr 2020Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.DeviceClass II3Terminated
17 Apr 2020Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.DeviceClass II2Terminated
6 Apr 2020System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and…DeviceClass II2Terminated
18 Feb 2020ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13DeviceClass II4Terminated
14 Feb 2020Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited…DeviceClass II3Terminated
10 Feb 2020Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.DeviceClass II1Terminated
24 Jan 2020ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be…DeviceClass II1Terminated
16 Jan 2020COHERENCE Oncologist, Model Nos. 07333680 & 07351898DeviceClass II1Terminated
8 Jan 2020SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.DeviceClass II4Terminated
8 Jan 2020Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as…DeviceClass II3Terminated
8 Jan 2020Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as…DeviceClass II3Terminated
20 Dec 2019Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
25 Nov 2019Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applicationDeviceClass II1Terminated
14 Nov 2019Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21CDeviceClass II1Terminated
7 Oct 2019Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100),…DeviceClass II1Terminated
24 Sep 2019SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray systemDeviceClass II1Terminated
31 Jul 2019SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission dataDeviceClass II7Terminated
30 Jul 2019Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen biplane 10848355; Artis zee ceiling 10094137; Artis Q ceiling 10848281;…DeviceClass II1Terminated
25 Jul 2019syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603DeviceClass II1Terminated
23 Jul 2019Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy proceduresDeviceClass II1Terminated
10 Jul 2019Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment…DeviceClass II4Terminated
9 Jul 2019MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914DeviceClass II4Terminated
3 Jul 2019SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images…DeviceClass II7Terminated
20 Jun 2019Cios Alpha VA20/ VA30 mobile X-Ray systemsDeviceClass II2Terminated
12 Jun 2019AXIOM Artis FC, Model Number 5904433DeviceClass II23Terminated
6 Jun 2019Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135DeviceClass II12Terminated
4 Jun 2019SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a…DeviceClass II4Terminated
28 May 2019SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a…DeviceClass II4Terminated
9 Apr 2019Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed…DeviceClass II4Terminated
22 Mar 2019Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional…DeviceClass II1Terminated
21 Mar 2019syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the physician in determining the functional…DeviceClass II2Terminated
20 Mar 2019Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control Console from…DeviceClass II1Terminated
18 Mar 2019Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic,…DeviceClass II1Terminated
14 Feb 2019SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.DeviceClass II4Terminated
8 Feb 2019Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).DeviceClass II2Terminated
28 Jan 2019ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver),…DeviceClass II4Ongoing
30 Nov 2018Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.DeviceClass II1Terminated
29 Nov 2018Sensis Vibe System, Model Number 11007642, with software version VD10B.DeviceClass II1Terminated
26 Oct 2018Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
19 Oct 2018ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with…DeviceClass II3Terminated
5 Oct 2018EVO Excel, Emission Computed Tomographic System, Material Number 10910501DeviceClass II1Terminated
28 Sep 2018Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.DeviceClass II2Terminated
6 Aug 2018AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.DeviceClass II3Terminated
3 Aug 2018Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with…DeviceClass II1Terminated
29 Jul 2018Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355DeviceClass II2Terminated
29 Jun 20183D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used…DeviceClass II2Terminated
22 Jun 2018Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.…DeviceClass II2Terminated
30 May 2018ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000DeviceClass II1Terminated
29 May 2018Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…DeviceClass II1Terminated
25 May 2018AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.DeviceClass II2Terminated
1 May 2018ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000DeviceClass II1Completed
1 May 2018Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.DeviceClass II12Terminated
20 Apr 2018SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.DeviceClass II2Terminated
27 Mar 2018Syngo.Via VB20A model 1049610DeviceClass II1Terminated
5 Mar 2018ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.DeviceClass II1Terminated
21 Feb 2018Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.DeviceClass II1Terminated
20 Feb 2018Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.…DeviceClass II2Terminated
15 Feb 2018SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.DeviceClass II15Terminated
14 Feb 2018MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.DeviceClass II6Terminated
1 Feb 2018SOMATOM Emotion 6 (Model 10165888)DeviceClass II7Terminated
26 Jan 2018Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.DeviceClass II1Terminated
26 Jan 2018ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal…DeviceClass II1Terminated
12 Jan 2018Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include cardiac angiography, neuro-angiography,…DeviceClass II1Terminated
10 Jan 2018Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.DeviceClass II1Terminated
8 Jan 2018Syngo.via. Medical Device Software. Picture archiving and communications system.DeviceClass II1Terminated
5 Jan 2018AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
8 Nov 2017SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic systemDeviceClass II4Terminated
7 Nov 2017Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution…DeviceClass II2Terminated
2 Oct 2017SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis.…DeviceClass II2Terminated
28 Sep 2017Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.DeviceClass II3Terminated
18 Sep 2017Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.DeviceClass II1Terminated
31 Aug 2017Syngo.via systems with SW VB20ADeviceClass II1Terminated
24 Aug 2017AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
23 Aug 2017Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and…DeviceClass II1Terminated
22 Aug 2017Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 PlusDeviceClass II1Terminated
18 Aug 2017Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital…DeviceClass II1Terminated
25 Jul 2017Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning.DeviceClass II1Terminated
6 Jun 2017Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355DeviceClass II3Terminated
22 May 2017Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment…DeviceClass II1Terminated
16 May 2017Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,DeviceClass II1Terminated
12 Apr 2017AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.DeviceClass II1Terminated
30 Mar 201718L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer – 10041227 & 10789400 S1000 – 10441701 S2000 – 10041461 S2000 (Refurb) - 10440017 S3000 – 10441730 Radiology: The ultrasound imaging systems are intended for the following…DeviceClass II1Terminated
28 Mar 2017Artis zee, Angiographic x-ray systemDeviceClass II1Terminated
6 Mar 2017Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports…DeviceClass II2Terminated
27 Feb 2017Artis Q and Q.Zen fluoroscopic x-ray systemDeviceClass II3Terminated
22 Feb 2017ARTIS Q, Interventional Fluroscopic x-ray systemDeviceClass II1Terminated
20 Feb 2017Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular)…DeviceClass II4Terminated
20 Feb 2017Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza…DeviceClass II1Terminated
14 Feb 2017ARTISTE" MV SystemDeviceClass II4Terminated
3 Feb 2017Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee include cardiac angiography,…DeviceClass II1Terminated
25 Jan 2017ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS” family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.DeviceClass II4Terminated
25 Jan 2017PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancerDeviceClass II6Terminated
11 Jan 2017Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft…DeviceClass II1Terminated
11 Jan 2017Syngo.plaza, picture archiving and communications system.DeviceClass II1Terminated
13 Dec 2016Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces…DeviceClass II11Terminated
8 Dec 2016Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis…DeviceClass II2Terminated
22 Nov 2016SOMATOM Scope, Computed tomography x-ray systemDeviceClass II3Terminated
15 Nov 2016SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.DeviceClass II3Terminated
7 Nov 2016Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal…DeviceClass II1Terminated
2 Nov 2016SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at…DeviceClass II3Terminated
1 Nov 2016Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego…DeviceClass II3Terminated
20 Oct 2016SOMATOM Force, System x-ray, tomography, computedDeviceClass II1Terminated
19 Oct 2016SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.DeviceClass II2Terminated
19 Oct 2016SOMATOM Definition AS system, x-ray, tomography, computedDeviceClass II2Terminated
17 Oct 2016Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI SystemsDeviceClass II1Terminated
6 Sep 2016Syngo.plaza, Picture Archiving and Communication SystemDeviceClass II2Terminated
5 Aug 2016e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.DeviceClass II1Terminated
5 Aug 2016Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.DeviceClass II2Terminated
2 Aug 2016Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.DeviceClass II2Terminated
1 Aug 2016Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric…DeviceClass II3Terminated
26 Jul 2016ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.DeviceClass II3Terminated
13 Jul 2016SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray systemDeviceClass II3Terminated
13 Jul 2016AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures…DeviceClass II3Terminated
7 Jul 2016Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging…DeviceClass II1Terminated
23 Jun 2016Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.DeviceClass II1Terminated
6 Jun 2016SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.DeviceClass II1Terminated
9 May 2016Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,DeviceClass II1Terminated
25 Apr 2016BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.DeviceClass II4Terminated
22 Apr 2016Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.DeviceClass II33Terminated
14 Apr 2016Syngo Dynamics; Kinetdx Picture Archiving and Communications SystemDeviceClass II1Terminated
13 Apr 2016MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.DeviceClass II1Terminated
8 Apr 2016ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.DeviceClass II1Terminated
1 Apr 2016SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.DeviceClass II1Terminated
31 Mar 2016E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.DeviceClass II1Terminated
22 Mar 2016SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.DeviceClass II1Terminated
11 Mar 2016Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography,…DeviceClass II1Terminated
2 Mar 2016Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.DeviceClass II4Terminated
26 Feb 2016system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
26 Feb 2016The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human bodyDeviceClass II2Terminated
24 Feb 2016syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .DeviceClass II1Terminated
19 Feb 2016AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.DeviceClass II2Terminated
19 Feb 2016Cios Alpha, mobile X-ray systemDeviceClass II1Terminated
18 Feb 2016Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with…DeviceClass II12Terminated
18 Feb 2016AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed…DeviceClass II2Terminated
16 Feb 2016CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic,…DeviceClass II1Terminated
15 Feb 2016Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.DeviceClass II8Terminated
12 Feb 2016Mammomat Inspiration with Tomosynthesis functionalityDeviceClass II1Terminated
29 Jan 2016software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.DeviceClass II1Terminated
25 Jan 2016Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report…DeviceClass II1Terminated
18 Jan 2016A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.DeviceClass II1Terminated
31 Dec 2015The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.DeviceClass II1Terminated
22 Dec 2015Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.DeviceClass II1Terminated
7 Dec 2015MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).DeviceClass II1Terminated
18 Nov 2015Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.DeviceClass II1Terminated
17 Nov 2015Syngo Imaging XS is a Picture Archiving and Communication System (PACS)DeviceClass II1Terminated
30 Oct 2015Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.DeviceClass II1Terminated
28 Oct 2015Syngo Imaging VB36D_HF02. Radiological image processing system.DeviceClass II1Terminated
7 Oct 2015ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.DeviceClass II1Terminated
24 Sep 2015MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.DeviceClass II1Terminated
5 Sep 2015ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 – ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following…DeviceClass II1Terminated
19 Aug 2015ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal…DeviceClass II1Terminated
18 Aug 2015SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.DeviceClass II1Terminated
17 Aug 2015CIOS ALPHA; image intensified fluoroscopic x-ray systemDeviceClass II1Terminated
14 Aug 2015SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.DeviceClass II3Terminated
11 Aug 2015Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of…DeviceClass II1Terminated
5 Aug 2015ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the…DeviceClass II1Terminated
31 Jul 2015Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.DeviceClass II3Terminated
14 Jul 2015Biograph mCT S(40)-4R, Model Number 10248671DeviceClass II8Terminated
6 Jul 2015Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.…DeviceClass II1Terminated
30 Jun 2015Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
29 Jun 2015ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000 18L6 - model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter…DeviceClass II1Terminated
29 Jun 2015Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational…DeviceClass II3Terminated
26 Jun 2015e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.DeviceClass II1Terminated
25 Jun 2015ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 – S 2000 system 10441730 – S 3000 system 10441701 – S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal,…DeviceClass II1Terminated
25 Jun 2015ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative,…DeviceClass II1Terminated
11 Jun 2015SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.DeviceClass II1Terminated
4 Jun 2015SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.DeviceClass II2Terminated
29 May 2015ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel,…DeviceClass II1Terminated
22 May 2015Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro…DeviceClass II1Terminated
15 May 2015Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.DeviceClass II1Terminated
6 May 2015syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints.DeviceClass II1Terminated
5 May 2015ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.DeviceClass II1Terminated
5 May 2015Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic,…DeviceClass II1Terminated
20 Apr 2015SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.DeviceClass II3Terminated
14 Apr 2015AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen,…DeviceClass II1Terminated
13 Apr 2015SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small…DeviceClass II4Terminated
19 Mar 2015Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general…DeviceClass II1Terminated
9 Mar 2015MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the…DeviceClass II1Terminated
18 Feb 2015Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.DeviceClass II1Terminated
6 Feb 2015SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at…DeviceClass II1Terminated
21 Jan 2015Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessoriesDeviceClass II1Terminated
16 Jan 2015Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose…DeviceClass II1Terminated
13 Jan 2015Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM…DeviceClass II1Terminated
12 Jan 2015ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.DeviceClass II1Terminated
12 Jan 2015ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative…DeviceClass II1Terminated
2 Jan 2015Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancerDeviceClass II1Terminated
19 Dec 2014LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300,…DeviceClass II1Terminated
15 Dec 2014Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and…DeviceClass II1Terminated
3 Dec 2014SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.DeviceClass II1Terminated
3 Dec 2014Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac…DeviceClass II1Terminated
2 Dec 2014Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2,…DeviceClass II1Terminated
19 Nov 2014ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.DeviceClass II1Terminated
13 Nov 2014Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.DeviceClass II5Terminated
11 Nov 2014Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.DeviceClass II1Terminated
28 Oct 2014Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.DeviceClass II1Terminated
10 Oct 2014Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.DeviceClass II1Terminated
23 Sep 2014Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac…DeviceClass II1Terminated
18 Sep 2014Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.DeviceClass II1Terminated
17 Sep 2014Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac…DeviceClass II1Terminated
2 Sep 2014Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used…DeviceClass II4Terminated
27 Aug 2014The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.DeviceClass II1Terminated
13 Aug 2014V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applicationsDeviceClass II1Terminated
12 Aug 2014AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric…DeviceClass II1Terminated
12 Aug 2014The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease,…DeviceClass II3Terminated
28 Jul 2014The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications. The Symbia…DeviceClass II2Terminated
7 Jul 2014Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.DeviceClass II1Terminated
30 Jun 2014Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also…DeviceClass II1Terminated
17 Jun 2014Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.DeviceClass II1Terminated
5 Jun 2014AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac…DeviceClass II1Terminated
5 Jun 2014Artis zee and Artis zeego systems. x-ray, angiographic systemDeviceClass II1Terminated
3 Jun 2014ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.DeviceClass II1Terminated
28 May 2014Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.DeviceClass II1Terminated
15 May 2014Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.DeviceClass II1Terminated
9 May 2014Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric…DeviceClass II1Terminated
9 May 2014Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.DeviceClass II1Terminated
6 May 2014Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.DeviceClass II1Terminated
25 Apr 2014MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.DeviceClass II1Terminated
24 Apr 2014MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.DeviceClass II1Terminated
23 Apr 2014e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear medicine diagnostic device.DeviceClass II2Terminated
23 Apr 2014ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.DeviceClass II1Terminated
23 Apr 2014ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.DeviceClass II1Terminated
11 Apr 2014AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a…DeviceClass II1Terminated
8 Apr 2014e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.DeviceClass II1Terminated
3 Apr 2014syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of…DeviceClass II1Terminated
3 Apr 2014Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.DeviceClass II1Terminated
2 Apr 2014Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.DeviceClass II1Terminated
1 Apr 2014550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.DeviceClass II1Terminated
1 Apr 2014Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancerDeviceClass II1Terminated
21 Mar 2014Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.DeviceClass II1Terminated
7 Mar 2014Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.DeviceClass II1Terminated
5 Mar 2014AXIOM Vertix MD Trauma systems radiographic X-rayDeviceClass II1Terminated
5 Mar 2014Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.DeviceClass II1Terminated
13 Feb 2014MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.DeviceClass II1Terminated
7 Feb 2014Artis Zee Angiographic x-ray systems.DeviceClass II1Terminated
7 Feb 2014AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.DeviceClass II1Terminated
27 Jan 2014syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673DeviceClass II1Terminated
22 Dec 2013ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic,…DeviceClass II1Terminated
22 Dec 2013ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.DeviceClass II1Terminated
16 Dec 2013Siemens Artis zee Ceiling Systems. Angiographic x-ray system.DeviceClass II1Terminated
11 Dec 2013SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de l’Esplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy…DeviceClass II1Terminated
5 Dec 2013Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-rayDeviceClass II1Terminated
5 Dec 2013PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to…DeviceClass II1Terminated
15 Nov 2013Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.DeviceClass II1Terminated
28 Oct 2013Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.DeviceClass II2Terminated
23 Oct 2013SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR…DeviceClass II2Terminated
11 Sep 2013The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.DeviceClass II1Terminated
3 Sep 2013Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray systemDeviceClass II1Terminated
3 Sep 2013(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray systemDeviceClass II1Terminated
28 Aug 2013Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray systemDeviceClass II1Terminated
16 Aug 2013Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the…DeviceClass II2Terminated
18 Jul 2013PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE”, ONCOR” and PRIMUS” family of linear accelerator systems is to deliver X-ray photon and electron radiation for the…DeviceClass II1Terminated
10 Jul 2013Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical…DeviceClass II1Terminated
26 Jun 2013ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray systemDeviceClass II1Terminated
10 Jun 2013syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo Dynamics is not intended to be used for reading mammography…DeviceClass II1Terminated
5 Jun 2013Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.DeviceClass II1Terminated
29 May 2013Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment…DeviceClass II1Terminated
29 May 2013ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.DeviceClass II1Terminated
13 May 2013Siemens AXIOM Artis zeego x-ray, angiographic systemDeviceClass II1Terminated
7 May 2013Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray systemDeviceClass II1Terminated
6 May 2013Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray SystemsDeviceClass II1Terminated
2 May 2013Mobiletta Mira Mobile X-ray SystemDeviceClass II1Terminated
26 Apr 2013Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.DeviceClass II1Terminated
4 Apr 2013Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.DeviceClass II1Terminated
28 Mar 2013Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal,…DeviceClass II1Terminated
8 Mar 2013Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray systemDeviceClass II1Terminated
5 Mar 2013SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR” and PRIMUS” family of…DeviceClass II9Terminated
4 Mar 2013Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological systemDeviceClass II1Terminated
28 Feb 2013Siemens Mammomat Inspiration - full-field digital mammography Product Usage: MammographyDeviceClass II1Terminated
31 Jan 2013Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray systemDeviceClass II1Terminated
21 Jan 2013Artis zee systems x-ray, angiographic systemDeviceClass II1Terminated
18 Jan 2013ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.DeviceClass II1Terminated
17 Jan 2013SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.DeviceClass II1Terminated
15 Jan 2013Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.DeviceClass II1Terminated
20 Dec 2012ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE” and ONCOR” family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.DeviceClass II1Terminated
27 Nov 2012Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.DeviceClass II1Terminated
26 Nov 2012Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray systemDeviceClass II1Terminated
23 Oct 2012The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and…DeviceClass II2Terminated
10 Oct 2012Siemens Mobilette Mira, intended use as Mobile x-ray system.DeviceClass II1Terminated
10 Oct 2012MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical lightDeviceClass II1Terminated
5 Oct 2012Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple…DeviceClass II1Terminated
12 Sep 2012Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic ImagerDeviceClass II1Terminated
21 Aug 2012Siemens Mobilett Mira. Mobile X-Ray System.DeviceClass II1Terminated
18 Jul 2012syngo Imaging XS. Radiological image processing system.DeviceClass II1Terminated
18 Jul 2012syngo.plaza, Model number 10592457. Intended use: radiological image processing system.DeviceClass II1Terminated
13 Jul 2012syngo Dynamics Version 9.5DeviceClass II1Terminated
11 Jul 2012ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative,…DeviceClass II1Terminated
25 Jun 2012ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.DeviceClass II1Terminated
20 Jun 2012Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing SystemDeviceClass II1Terminated
6 Jun 2012Siemens syngo.plaza radiological image processing system.DeviceClass II1Terminated
11 May 2012ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal,…DeviceClass II1Terminated
30 Apr 2012Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray systemDeviceClass II1Terminated
30 Apr 2012Siemens Uroskop Access. Fluoroscopic, image intensified x-ray systemDeviceClass II1Terminated
11 Apr 2012Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.DeviceClass II2Terminated
24 Feb 2012Siemens syngo.plaza. Radiological image processing systemDeviceClass II1Terminated
8 Aug 2011Siemens syngo.plaza image processing system image processing radiological systemDeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Siemens Medical Solutions USA, Inc: events for each product type
TypeEvents
Device400
Siemens Medical Solutions USA, Inc: events in each class
ClassEvents
Class II397
Class I2
Class III1
Share of the events of the firm in Class I
1%
Share of all events on the register in Class I
18%
Events with the status Ongoing
69

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Siemens Medical Solutions USA, Inc, by the year that the recall started. The largest year is 2014, with 50 events.

Official channels

Cite this page

Recall Register. Siemens Medical Solutions USA, Inc: FDA recalls. https://recallregister.com/firm/siemens-medical-solutions-usa-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
PA, CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Siemens Medical Solutions USA, Inc have?
Class II: 397 events. Class I: 2 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Siemens Medical Solutions USA, Inc?
FDA event 99224, which the firm started on 8 Jun 2026. The first product in the record is: ARTIS icono ceiling. Model Number: 11328100.
How many FDA recalls of Siemens Medical Solutions USA, Inc have the status Ongoing?
69 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.