Recall archive
37 recalls · page 1 of 2
Reported Jul 22, 2026
Optima XR200amx, Mobile Digital-Ready Radiographic System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Reason for recall — GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Allia IGS 3 Pulse angiographic X-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue…
4 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Reason for recall — GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 1, 2026
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip…
FDA (openFDA device enforcement)
Reported Mar 25, 2026
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Reason for recall — Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR…
FDA (openFDA device enforcement)
Reported Oct 29, 2025
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand — If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the…
FDA (openFDA device enforcement)
Reported Oct 22, 2025
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand — The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
GE HealthCare OEC 9800.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — 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,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2025
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect,…
21 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
SIGNA Architect
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Reason for recall — GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand — OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product details · Reason for recall — The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product details — 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…
FDA (openFDA device enforcement)
Reported Jan 15, 2025
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — 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…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Discovery MR750w 3.0T, whole body magnetic resonance scanner
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Reason for recall — Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 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,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product details · Reason for recall — 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…
25 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 31, 2018
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 24, 2018
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally…
FDA (openFDA device enforcement)
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