GE Medical Systems, LLC

FDA recalling firm · 42 enforcement events · 168 product records · 2015–2026 · WI

GE Medical Systems, LLC has 42 FDA enforcement events on this register (168 product records) between 2015 and 2026: 42 device; the busiest year was 2025 with 10.

0% of its events are Class I; the most common class is Class II (42). 24 events are listed as ongoing; the recalling firm's address is in WI.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
5 Jun 2026	Optima XR200amx, Mobile Digital-Ready Radiographic System	Device	Class II	3	Ongoing
1 May 2026	Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models	Device	Class II	3	Ongoing
20 Apr 2026	Allia IGS 3 Pulse angiographic X-ray system	Device	Class II	5	Ongoing
26 Mar 2026	Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300	Device	Class II	7	Ongoing
3 Feb 2026	Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP	Device	Class II	1	Ongoing
30 Jan 2026	Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026,…	Device	Class II	3	Ongoing
24 Oct 2025	Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography	Device	Class II	1	Ongoing
18 Sep 2025	LOGIQ P10 series with software version R4.5.7 Model Number 5877534	Device	Class II	3	Ongoing
22 Aug 2025	MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4	Device	Class II	1	Ongoing
2 Jul 2025	GE HealthCare OEC 9800.	Device	Class II	2	Ongoing
20 Jun 2025	GE Signa Artist, Nuclear Magnetic Resonance Imaging System	Device	Class II	22	Ongoing
23 May 2025	SIGNA Architect	Device	Class II	4	Ongoing
21 Mar 2025	OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.	Device	Class II	2	Ongoing
6 Mar 2025	Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX ), R3 Pro for China (Model Number…	Device	Class II	2	Ongoing
18 Feb 2025	GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed	Device	Class II	7	Ongoing
28 Jan 2025	Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.	Device	Class II	4	Ongoing
6 Dec 2024	Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB	Device	Class II	1	Ongoing
25 Nov 2024	GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB	Device	Class II	3	Ongoing
18 Nov 2024	Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992	Device	Class II	5	Ongoing
28 Oct 2024	Discovery MR750w 3.0T, whole body magnetic resonance scanner	Device	Class II	4	Ongoing
14 Jun 2024	SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System	Device	Class II	26	Ongoing
16 Nov 2022	B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,	Device	Class II	5	Ongoing
10 Nov 2022	Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate);…	Device	Class II	8	Ongoing
28 Oct 2022	Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.	Device	Class II	2	Ongoing
3 Oct 2018	SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner 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,…	Device	Class II	1	Terminated
7 Jun 2018	GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350), 1.5T SIGNA ECHOSPEED, 1.5T SIGNA EXCITE,…	Device	Class II	3	Terminated
6 Jun 2018	Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T…	Device	Class II	1	Terminated
30 Mar 2018	MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise ratio, with short scan times. The Signa¿…	Device	Class II	1	Terminated
11 May 2017	Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner 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,…	Device	Class II	9	Terminated
20 Apr 2016	GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications	Device	Class II	1	Terminated
15 Apr 2016	GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.	Device	Class II	2	Terminated
15 Mar 2016	GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).	Device	Class II	1	Terminated
1 Mar 2016	SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner 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…	Device	Class II	1	Terminated
17 Feb 2016	GE Healthcare, Aisys CS2 anesthesia..	Device	Class II	2	Terminated
10 Feb 2016	LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron…	Device	Class II	6	Terminated
23 Dec 2015	GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.	Device	Class II	3	Terminated
18 Dec 2015	Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ	Device	Class II	1	Terminated
15 Dec 2015	GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for…	Device	Class II	6	Terminated
7 Dec 2015	GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.	Device	Class II	2	Terminated
13 Nov 2015	GE Healthcare Optima CL323i 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 and interventional procedures. Additionally, with the OR…	Device	Class II	2	Terminated
23 Oct 2015	GE Healthcare, Revolution CT Scanners. 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…	Device	Class II	1	Terminated
23 Sep 2015	MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS	Device	Class II	1	Terminated

By type and class

Device42

Class II42

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for GE Medical Systems, LLC by year initiated.

Questions and answers

How many FDA recalls has GE Medical Systems, LLC had?

42 enforcement events (168 product records) on this register, 2015–2026: 42 device.

Are any GE Medical Systems, LLC recalls ongoing?

24 events are listed as ongoing in the current openFDA export.

What class are GE Medical Systems, LLC recalls?

42 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.