GE Medical Systems, LLC

Complete recall history across all FDA and CPSC categories — 150 total recalls

GE Medical Systems, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (150)

FDA medical device enforcement actions by GE Medical Systems, LLC. Showing most recent 50.

Date Product Reason Class
Feb 3, 2026 Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (... There is a potential issue that can lead to discordance between the simulated... Class II
Jan 30, 2026 Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a devi... There is a potential cybersecurity vulnerability affecting certain versions o... Class II
Jan 30, 2026 Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a... There is a potential cybersecurity vulnerability affecting certain versions o... Class II
Jan 30, 2026 Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a dev... There is a potential cybersecurity vulnerability affecting certain versions o... Class II
Oct 24, 2025 Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening ... Some Senographe Pristina systems either have a missing or an incorrect X-Ray ... Class II
Sep 18, 2025 LOGIQ P10 series with software version R4.5.7 Model Number 5877534 The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may displ... Class II
Sep 18, 2025 LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model N... The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may displ... Class II
Sep 18, 2025 LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Mod... The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may displ... Class II
Aug 22, 2025 MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multic... If a user incorrectly places the Acquisition Module into the Acquisition Modu... Class II
Jul 2, 2025 GE HealthCare OEC 9800. GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in ... Class II
Jul 2, 2025 GE HealthCare OEC 9900 Elite C-arm Systems. GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in ... Class II
Jun 20, 2025 GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography wi... GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE Signa Voyager, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
Jun 20, 2025 GE Signa Artist, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIG... Class II
May 23, 2025 Discovery MR750w 3.0T GE HealthCare has become aware that gradient coils for certain MR systems (se... Class II
May 23, 2025 SIGNA PET/MR GE HealthCare has become aware that gradient coils for certain MR systems (se... Class II
May 23, 2025 SIGNA Architect AIR GE HealthCare has become aware that gradient coils for certain MR systems (se... Class II
May 23, 2025 SIGNA Architect GE HealthCare has become aware that gradient coils for certain MR systems (se... Class II
Mar 21, 2025 OEC 3D OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X... Class II
Mar 21, 2025 OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and... OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X... Class II
Mar 6, 2025 Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number ... The battery for certain ultrasound systems can potentially develop an interna... Class II
Mar 6, 2025 Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (... The battery for certain ultrasound systems can potentially develop an interna... Class II
Feb 18, 2025 GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT ... Class II
Feb 18, 2025 GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT ... Class II
Feb 18, 2025 GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT ... Class II
Feb 18, 2025 GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT ... Class II
Feb 18, 2025 GE Healthcare Revolution CT, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT ... Class II
Feb 18, 2025 GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT ... Class II
Feb 18, 2025 GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT ... Class II
Jan 28, 2025 Discovery XR656HD. X-Ray imaging system. The user can continue to take the next exposure after reaching the Automatic ... Class II
Jan 28, 2025 Discovery XR656 HD. X-Ray imaging system. The user can continue to take the next exposure after reaching the Automatic ... Class II

View all 150 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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