| 27 Feb 2026 | SIGNA Premier systems | Device | Class II | 1 | Ongoing |
| 15 Jul 2022 | (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x. | Device | Class II | 1 | Ongoing |
| 24 Jun 2022 | SIGNA Premier magnetic resonance scanner, model 5748519. | Device | Class II | 1 | Ongoing |
| 14 Jun 2022 | Centricity PACS Software Version 7.0 SP0.0.4.7 | Device | Class II | 1 | Terminated |
| 8 Jun 2022 | GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation. | Device | Class II | 1 | Ongoing |
| 2 Jun 2022 | Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/CT systems. | Device | Class II | 1 | Ongoing |
| 1 Jun 2022 | GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000. | Device | Class I | 1 | Terminated |
| 27 May 2022 | GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000. | Device | Class II | 1 | Ongoing |
| 10 May 2022 | CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200… | Device | Class II | 1 | Ongoing |
| 28 Apr 2022 | Centricity Universal Viewer Zero Footprint Client | Device | Class II | 5 | Ongoing |
| 25 Apr 2022 | Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019 | Device | Class II | 2 | Ongoing |
| 18 Apr 2022 | Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116) | Device | Class I | 2 | Ongoing |
| 16 Mar 2022 | MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008 | Device | Class II | 1 | Terminated |
| 4 Mar 2022 | GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA… | Device | Class II | 1 | Ongoing |
| 18 Feb 2022 | Signa 1.5T TwinSpeed Magnetic Resonance Imaging System | Device | Class II | 4 | Ongoing |
| 28 Jan 2022 | GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001. | Device | Class II | 1 | Ongoing |
| 23 Dec 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system. | Device | Class II | 32 | Ongoing |
| 4 Nov 2021 | GE Vscan Extend, being sold as "Vscan Extend Console" | Device | Class II | 7 | Terminated |
| 15 Oct 2021 | GE Centricity Universal Viewer Zero Footprint Client | Device | Class II | 1 | Terminated |
| 26 Aug 2021 | SIGNA Premier nuclear magnetic resonance imaging system | Device | Class II | 10 | Terminated |
| 12 Aug 2021 | Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system | Device | Class II | 1 | Terminated |
| 6 Aug 2021 | Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. | Device | Class II | 2 | Ongoing |
| 2 Aug 2021 | Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable)… | Device | Class II | 2 | Ongoing |
| 30 Jun 2021 | The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart,… | Device | Class II | 3 | Ongoing |
| 30 Jun 2021 | Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | Device | Class II | 1 | Ongoing |
| 30 Jun 2021 | Revolution Apex, Revolution CT with Apex Edition | Device | Class II | 2 | Ongoing |
| 24 Jun 2021 | AMX Navigate Mobile X-Ray System | Device | Class II | 1 | Terminated |
| 14 Jun 2021 | Revolution EVO, Optima CT660, Optima CT680 CT Systems. | Device | Class II | 1 | Ongoing |
| 4 Jun 2021 | SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. | Device | Class II | 14 | Ongoing |
| 21 May 2021 | CARESCAPE PDM-Masimo SpO2. Physiological data monitor. | Device | Class II | 1 | Ongoing |
| 19 Apr 2021 | Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application | Device | Class II | 1 | Terminated |
| 19 Apr 2021 | GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems. | Device | Class II | 1 | Terminated |
| 19 Mar 2021 | Revolution CT | Device | Class II | 1 | Completed |
| 19 Mar 2021 | Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. | Device | Class II | 1 | Terminated |
| 7 Feb 2021 | NM/CT 850 Nuclear Medicine / CT Scanners | Device | Class II | 3 | Ongoing |
| 17 Dec 2020 | System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition | Device | Class II | 2 | Terminated |
| 10 Dec 2020 | GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. | Device | Class II | 6 | Terminated |
| 10 Dec 2020 | GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen,… | Device | Class II | 1 | Terminated |
| 23 Nov 2020 | Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | Device | Class II | 2 | Terminated |
| 27 Oct 2020 | MAC VU360, Electrocardiograph | Device | Class II | 1 | Terminated |
| 21 Sep 2020 | Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | Device | Class II | 1 | Terminated |
| 17 Sep 2020 | Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the… | Device | Class II | 7 | Ongoing |
| 8 Sep 2020 | System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. | Device | Class II | 5 | Terminated |
| 14 Aug 2020 | NM/CT 850 Model Number: H3907AD | Device | Class II | 8 | Terminated |
| 14 Jul 2020 | CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume. | Device | Class II | 1 | Terminated |
| 22 Jun 2020 | CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. | Device | Class II | 1 | Terminated |
| 18 May 2020 | CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474 2042084-001-053034 2042084-001-215165… | Device | Class II | 1 | Ongoing |
| 28 Apr 2020 | Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer. | Device | Class II | 2 | Terminated |
| 2 Apr 2020 | Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808. | Device | Class II | 1 | Terminated |
| 23 Dec 2019 | SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. | Device | Class II | 4 | Terminated |
| 16 Dec 2019 | Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources. | Device | Class II | 1 | Terminated |
| 3 Dec 2019 | Lunar iDXA bone densitometer | Device | Class II | 4 | Ongoing |
| 25 Nov 2019 | Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult. | Device | Class I | 2 | Terminated |
| 12 Nov 2019 | ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this… | Device | Class II | 3 | Terminated |
| 11 Oct 2019 | Giraffe OmniBed infant warmer | Device | Class I | 4 | Terminated |
| 27 Sep 2019 | CARESCAPE Respiratory Module E-sCO | Device | Class I | 7 | Terminated |
| 16 Sep 2019 | CardioLab/ComboLab Recording Systems | Device | Class II | 1 | Terminated |
| 3 Sep 2019 | Achilles Insight Bone Sonometer | Device | Class II | 2 | Terminated |
| 30 Aug 2019 | ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures… | Device | Class II | 1 | Ongoing |
| 9 Aug 2019 | Proteus XR/a (SlOK : K993090) | Device | Class II | 1 | Ongoing |
| 26 Jul 2019 | Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to… | Device | Class II | 1 | Ongoing |
| 19 Jul 2019 | Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n)… | Device | Class II | 4 | Terminated |
| 2 Jul 2019 | Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D | Device | Class II | 2 | Terminated |
| 28 Jun 2019 | MAC VU360, Model Number 2030360-001, Electrocardiograph | Device | Class II | 1 | Terminated |
| 22 May 2019 | GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x | Device | Class II | 1 | Terminated |
| 21 May 2019 | LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector… | Device | Class II | 1 | Ongoing |
| 17 May 2019 | Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and… | Device | Class II | 2 | Terminated |
| 16 May 2019 | GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems. | Device | Class II | 2 | Terminated |
| 16 May 2019 | Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. | Device | Class II | 2 | Terminated |
| 10 May 2019 | ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft. 2106306-001 ECG Trunk Cable, Neonatal, DIN… | Device | Class III | 5 | Terminated |
| 29 Mar 2019 | Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system. | Device | Class II | 5 | Terminated |
| 20 Mar 2019 | Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging… | Device | Class II | 10 | Terminated |
| 19 Mar 2019 | AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems. | Device | Class II | 1 | Terminated |
| 15 Mar 2019 | Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open… | Device | Class I | 2 | Terminated |
| 15 Mar 2019 | Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. | Device | Class II | 3 | Ongoing |
| 22 Feb 2019 | Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment… | Device | Class III | 1 | Terminated |
| 12 Feb 2019 | Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. | Device | Class II | 6 | Ongoing |
| 19 Jan 2019 | Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | Device | Class II | 1 | Ongoing |
| 28 Dec 2018 | GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and… | Device | Class II | 1 | Terminated |
| 20 Dec 2018 | GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this… | Device | Class II | 1 | Terminated |
| 30 Nov 2018 | System, Tomography Computed Emmission | Device | Class II | 2 | Ongoing |
| 15 Nov 2018 | Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use | Device | Class II | 1 | Terminated |
| 9 Nov 2018 | Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect. | Device | Class II | 1 | Terminated |
| 11 Oct 2018 | Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources. | Device | Class II | 2 | Terminated |
| 5 Oct 2018 | GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860… | Device | Class I | 1 | Terminated |
| 27 Sep 2018 | Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. | Device | Class II | 3 | Terminated |
| 25 Sep 2018 | Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1 | Device | Class II | 6 | Terminated |
| 14 Sep 2018 | GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal… | Device | Class II | 1 | Terminated |
| 14 Sep 2018 | GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System | Device | Class I | 3 | Terminated |
| 11 Sep 2018 | PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during… | Device | Class II | 5 | Ongoing |
| 31 Aug 2018 | Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. | Device | Class II | 6 | Ongoing |
| 30 Aug 2018 | Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. | Device | Class II | 1 | Terminated |
| 12 Jul 2018 | Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | Device | Class II | 1 | Ongoing |
| 24 May 2018 | Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. | Device | Class II | 3 | Completed |
| 24 May 2018 | Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22 | Device | Class II | 10 | Terminated |
| 15 Dec 2017 | Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals… | Device | Class II | 2 | Terminated |
| 30 Oct 2017 | Discover VH/Millennium VG Nuclear Medicine Imaging System | Device | Class II | 2 | Completed |
| 4 Oct 2017 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. | Device | Class II | 2 | Terminated |
| 19 May 2017 | GE Healthcare Revolution EVO X-ray system | Device | Class II | 16 | Terminated |
| 5 May 2017 | Infant Warmer System (IWS) | Device | Class II | 1 | Terminated |
| 2 May 2017 | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | Device | Class II | 1 | Terminated |
| 10 Mar 2017 | Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. | Device | Class II | 2 | Terminated |
| 6 Feb 2017 | Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems | Device | Class II | 1 | Terminated |
| 20 Jan 2017 | Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps. and/or… | Device | Class II | 1 | Terminated |
| 21 Nov 2016 | Innova 2000 | Device | Class II | 13 | Terminated |
| 3 Nov 2016 | GE Healthcare, Avance, Avance CS2, Amingo. | Device | Class II | 1 | Terminated |
| 16 Sep 2016 | Brivo XR385, model 5215463, Digital Diagnostic Radiographic System | Device | Class II | 1 | Terminated |
| 31 Aug 2016 | GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. | Device | Class II | 1 | Terminated |
| 4 Aug 2016 | Infant Warmer System (IWS) | Device | Class II | 1 | Terminated |
| 8 Jun 2016 | GE Healthcare, Discovery MR750w | Device | Class II | 1 | Terminated |
| 9 May 2016 | MSK 1.5T Extreme MR Scanner, a diagnostic imaging device | Device | Class II | 2 | Terminated |
| 9 May 2016 | GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. | Device | Class II | 1 | Terminated |
| 14 Oct 2014 | GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM,… | Device | Class II | 6 | Terminated |
| 19 Sep 2014 | GE Healthcare Carescape Patient Data Module | Device | Class II | 1 | Terminated |
| 5 Sep 2014 | GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations. | Device | Class II | 1 | Terminated |
| 4 Sep 2014 | Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. | Device | Class II | 3 | Terminated |
| 8 Aug 2014 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5… | Device | Class II | 1 | Terminated |
| 25 Jul 2014 | GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages. | Device | Class II | 1 | Terminated |
| 7 Jul 2014 | GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. | Device | Class II | 1 | Terminated |
| 13 Jun 2014 | GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. | Device | Class II | 1 | Terminated |
| 11 Jun 2014 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients. | Device | Class I | 1 | Terminated |
| 4 Jun 2014 | GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications. | Device | Class II | 2 | Terminated |
| 23 May 2014 | GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status. | Device | Class II | 1 | Terminated |
| 2 May 2014 | Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers:… | Device | Class II | 1 | Terminated |
| 23 Apr 2014 | GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices. | Device | Class II | 1 | Terminated |
| 9 Apr 2014 | GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. | Device | Class II | 1 | Terminated |
| 7 Apr 2014 | GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. | Device | Class II | 1 | Terminated |
| 2 Apr 2014 | GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device. | Device | Class II | 1 | Terminated |
| 27 Mar 2014 | GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging. | Device | Class II | 1 | Terminated |
| 28 Feb 2014 | GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on… | Device | Class II | 1 | Terminated |
| 14 Feb 2014 | GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes,… | Device | Class II | 1 | Terminated |
| 13 Feb 2014 | GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare… | Device | Class II | 1 | Terminated |
| 7 Feb 2014 | GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is… | Device | Class II | 3 | Terminated |
| 20 Jan 2014 | GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams,… | Device | Class II | 1 | Terminated |
| 27 Dec 2013 | GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal… | Device | Class II | 1 | Terminated |
| 20 Dec 2013 | CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system… | Device | Class II | 1 | Terminated |
| 16 Dec 2013 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) | Device | Class II | 1 | Terminated |
| 12 Dec 2013 | GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems… | Device | Class II | 1 | Terminated |
| 11 Dec 2013 | GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in generating… | Device | Class II | 1 | Terminated |
| 5 Dec 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner.… | Device | Class II | 3 | Terminated |
| 27 Nov 2013 | GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. | Device | Class II | 1 | Terminated |
| 27 Nov 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station. | Device | Class II | 1 | Terminated |
| 20 Nov 2013 | GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.… | Device | Class II | 1 | Terminated |
| 15 Nov 2013 | GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic… | Device | Class II | 1 | Terminated |
| 8 Nov 2013 | Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and… | Device | Class II | 1 | Terminated |
| 7 Nov 2013 | GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698. | Device | Class II | 1 | Terminated |
| 25 Oct 2013 | GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma,… | Device | Class II | 1 | Terminated |
| 11 Oct 2013 | GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved… | Device | Class II | 1 | Terminated |
| 11 Oct 2013 | HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and… | Device | Class II | 1 | Terminated |
| 9 Oct 2013 | GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. | Device | Class II | 1 | Terminated |
| 1 Oct 2013 | GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of… | Device | Class I | 3 | Terminated |
| 19 Sep 2013 | Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare… | Device | Class I | 1 | Terminated |
| 19 Sep 2013 | AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When… | Device | Class II | 1 | Terminated |
| 16 Sep 2013 | GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. | Device | Class I | 1 | Terminated |
| 30 Aug 2013 | GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray… | Device | Class II | 1 | Terminated |
| 28 Aug 2013 | GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation. | Device | Class I | 1 | Terminated |
| 16 Aug 2013 | GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies. | Device | Class II | 1 | Terminated |
| 13 Aug 2013 | GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T. scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images,… | Device | Class II | 1 | Terminated |
| 7 Aug 2013 | GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic… | Device | Class II | 1 | Terminated |
| 29 Jul 2013 | Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The… | Device | Class II | 1 | Terminated |
| 19 Jun 2013 | GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the… | Device | Class II | 1 | Terminated |
| 13 Jun 2013 | GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear… | Device | Class I | 7 | Terminated |
| 14 May 2013 | Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support. | Device | Class II | 1 | Terminated |
| 9 May 2013 | GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced – vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced – vxtl.11.3, vxtl.11.3… | Device | Class II | 1 | Terminated |
| 2 May 2013 | GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations. | Device | Class II | 1 | Terminated |
| 10 Apr 2013 | The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging… | Device | Class II | 1 | Terminated |
| 9 Apr 2013 | GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w… | Device | Class II | 1 | Terminated |
| 3 Apr 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. | Device | Class II | 3 | Terminated |
| 28 Mar 2013 | MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand. | Device | Class II | 2 | Terminated |
| 26 Mar 2013 | GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. | Device | Class II | 2 | Terminated |
| 8 Feb 2013 | GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation. | Device | Class II | 1 | Terminated |
| 21 Jan 2013 | GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2. | Device | Class II | 1 | Terminated |
| 14 Jan 2013 | GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems. | Device | Class II | 1 | Terminated |
| 9 Jan 2013 | Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures. | Device | Class II | 1 | Terminated |
| 8 Jan 2013 | Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer. | Device | Class I | 1 | Terminated |
| 9 Nov 2012 | GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN &… | Device | Class II | 1 | Terminated |
| 15 Oct 2012 | GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. | Device | Class I | 2 | Terminated |
| 12 Oct 2012 | GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to,… | Device | Class II | 1 | Terminated |
| 26 Sep 2012 | GE Healthcare Definium 5000 / 5220493 X-Ray System | Device | Class II | 2 | Terminated |
| 20 Sep 2012 | GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality… | Device | Class II | 1 | Terminated |
| 20 Sep 2012 | GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body. | Device | Class II | 4 | Terminated |
| 16 Aug 2012 | GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally,… | Device | Class II | 1 | Terminated |
| 13 Aug 2012 | GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and… | Device | Class II | 1 | Terminated |
| 7 Aug 2012 | GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen,… | Device | Class II | 1 | Terminated |
| 3 Aug 2012 | GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System | Device | Class II | 1 | Terminated |
| 1 Aug 2012 | GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace… | Device | Class II | 3 | Terminated |
| 20 Jul 2012 | CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of… | Device | Class II | 1 | Terminated |
| 13 Jul 2012 | GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ… | Device | Class II | 1 | Terminated |
| 12 Jul 2012 | GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient… | Device | Class II | 1 | Terminated |
| 10 Jul 2012 | Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. | Device | Class II | 2 | Terminated |
| 28 Jun 2012 | GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are… | Device | Class II | 1 | Terminated |
| 26 Jun 2012 | GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor… | Device | Class II | 1 | Terminated |
| 26 Jun 2012 | GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713… | Device | Class I | 1 | Terminated |
| 13 Jun 2012 | GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients. | Device | Class II | 1 | Terminated |
| 13 Jun 2012 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. | Device | Class II | 1 | Terminated |
| 12 Jun 2012 | GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004. | Device | Class II | 1 | Terminated |
| 8 Jun 2012 | GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device. | Device | Class II | 3 | Terminated |
| 29 May 2012 | Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share… | Device | Class II | 1 | Terminated |
| 25 May 2012 | GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional… | Device | Class II | 1 | Terminated |
| 24 May 2012 | GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. | Device | Class II | 1 | Terminated |
| 24 May 2012 | GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When… | Device | Class II | 1 | Terminated |
| 24 May 2012 | AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. | Device | Class II | 1 | Terminated |
| 24 May 2012 | GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from… | Device | Class II | 1 | Terminated |
| 24 May 2012 | GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis… | Device | Class II | 1 | Terminated |
| 23 Apr 2012 | GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body,… | Device | Class II | 1 | Terminated |
| 10 Apr 2012 | GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. | Device | Class I | 1 | Terminated |
| 4 Apr 2012 | GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR ) | Device | Class II | 1 | Terminated |
| 27 Mar 2012 | GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. | Device | Class II | 1 | Terminated |
| 6 Mar 2012 | GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations. | Device | Class II | 1 | Terminated |
| 17 Feb 2012 | GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes. | Device | Class II | 1 | Terminated |
| 23 Jan 2012 | VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care,… | Device | Class II | 1 | Terminated |
| 4 Jan 2012 | GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage… | Device | Class II | 1 | Terminated |
| 20 Dec 2011 | GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images… | Device | Class II | 3 | Terminated |
| 20 Dec 2011 | GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures. | Device | Class II | 1 | Terminated |
| 21 Nov 2011 | SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and… | Device | Class II | 1 | Terminated |
| 21 Oct 2011 | GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System. | Device | Class II | 1 | Terminated |
| 6 Oct 2011 | GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence,… | Device | Class II | 1 | Terminated |
| 30 Sep 2011 | GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient… | Device | Class II | 1 | Terminated |
| 25 Jul 2011 | GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission. | Device | Class II | 1 | Terminated |
| 20 Jul 2011 | GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility. | Device | Class II | 1 | Terminated |
| 16 May 2011 | GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. | Device | Class II | 1 | Terminated |
| 10 May 2011 | Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. | Device | Class II | 1 | Terminated |
| 5 Apr 2011 | GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated… | Device | Class II | 1 | Terminated |
| 25 Mar 2011 | GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4).… | Device | Class II | 1 | Terminated |
| 4 Feb 2011 | GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy. | Device | Class II | 1 | Terminated |