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 |
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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