GE Medical Systems recalls
24 official recalls and safety alerts involving GE Medical Systems since 2022-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with GE Medical Systems or the relevant agency.
- 2026-07-22
USGE Medical Systems, LLC recalls Optima XR200amx, Mobile Digital-Ready Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly.…
FDA · DeviceGE Medical Systems, LLCWorldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico,…Official notice →- 2026-06-24
- US
GE Medical Systems, LLC recalls Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners…
- 2026-06-17
- US
GE Medical Systems, LLC recalls Allia IGS 3 Pulse angiographic X-ray system
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel…
- 2026-05-20
- US
GE Medical Systems, LLC recalls Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution…
- 2026-04-01
- US
GE Medical Systems, LLC recalls Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
- 2026-03-25
- US
GE Medical Systems, LLC recalls Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and…
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized…
- 2025-12-17
- US
GE Medical Systems, LLC recalls Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
- 2025-10-29
- US
GE Medical Systems, LLC recalls MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001,…
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires.…
FDA · DeviceGE Medical Systems, LLCWorldwide Distribution: US (nationwide) and OUS (foreign/Global) to countries…Official notice → - 2025-10-22
- US
GE Medical Systems, LLC recalls LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- 2025-09-03
- US
GE Medical Systems, LLC recalls GE HealthCare OEC 9900 Elite C-arm Systems.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator…
- 2025-08-20
- US
GE Medical Systems, LLC recalls GE Signa Artist, Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T,…
- 2025-07-30
- US
GE Medical Systems, LLC recalls SIGNA Architect
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result,…
FDA · DeviceGE Medical Systems, LLCWorldwide distribution - US Nationwide and the country of China.Official notice → - 2025-06-18
- US
GE Medical Systems, LLC recalls OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional…
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
- 2025-04-23
- US
GE Medical Systems, LLC recalls Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG,…
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
- 2025-03-19
- US
GE Medical Systems, LLC recalls GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol)…
- 2025-02-12
- US
GE Medical Systems, LLC recalls Optima XR646 HD. X-Ray imaging system.
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still…
FDA · DeviceGE Medical Systems, LLCWorldwide Distribution: US (nationwide) including Puerto Rico and OUS…Official notice → - 2025-01-22
- US
GE Medical Systems, LLC recalls Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring…
There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
FDA · DeviceGE Medical Systems, LLCWorldwide - US Nationwide distribution in the states of OH, TX and the…Official notice → - 2025-01-15
- US
GE Medical Systems, LLC recalls Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- US
GE Medical Systems, LLC recalls GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB;…
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and…
- 2024-12-04
- US
GE Medical Systems, LLC recalls SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
FDA · DeviceGE Medical Systems, LLCWorldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - 2024-08-14
- US
GE Medical Systems, LLC recalls SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D…
- 2022-12-28
- US
GE Medical Systems, LLC recalls Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes,…
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
FDA · DeviceGE Medical Systems, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
GE Medical Systems, LLC recalls B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that…
- US
GE Medical Systems, LLC recalls Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in…
FDA · DeviceGE Medical Systems, LLCNationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND,…Official notice →