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
Jun 5, 2026 Optima XR240amx, Mobile Digital Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx system... Class II
Jun 5, 2026 Optima XR220amx, Mobile Digital-Ready Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx system... Class II
Jun 5, 2026 Optima XR200amx, Mobile Digital-Ready Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx system... Class II
May 1, 2026 Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combinati... GE HealthCare has become aware of a potential issue involving the canopy soff... Class II
May 1, 2026 Giraffe OmniBed, a combination of an infant incubator and an infant warmer, A... GE HealthCare has become aware of a potential issue involving the canopy soff... Class II
May 1, 2026 Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and... GE HealthCare has become aware of a potential issue involving the canopy soff... Class II
Apr 20, 2026 Allia IGS 7 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical c... Class II
Apr 20, 2026 Allia IGS 5 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical c... Class II
Apr 20, 2026 Allia Moveo angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical c... Class II
Apr 20, 2026 Allia IGS Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical c... Class II
Apr 20, 2026 Allia IGS 3 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical c... Class II
Mar 26, 2026 Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 GE HealthCare has become aware of a potential security vulnerability impactin... Class II
Mar 26, 2026 Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 GE HealthCare has become aware of a potential security vulnerability impactin... Class II
Mar 26, 2026 Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 GE HealthCare has become aware of a potential security vulnerability impactin... Class II
Mar 26, 2026 Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 GE HealthCare has become aware of a potential security vulnerability impactin... Class II
Mar 26, 2026 Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 GE HealthCare has become aware of a potential security vulnerability impactin... Class II
Mar 26, 2026 Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000... GE HealthCare has become aware of a potential security vulnerability impactin... Class II
Mar 26, 2026 Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 GE HealthCare has become aware of a potential security vulnerability impactin... Class II
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

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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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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