FDA recall record · openFDA
GE Medical Systems, LLC
103 FDA recalls on record (2024–2026) — 103 device. 103 still ongoing.
0
Class I (most serious)
103
Class II
0
Class III
103
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user 26
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR 22
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link 7
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (plea 7
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than th 5
Recalls
Allia IGS 3 Pulse angiographic X-ray system Class II 2026-04-20 Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 Class II 2026-03-26 Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 Class II 2026-03-26 Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8 Class II 2026-02-03 Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 Class II 2026-03-26 Allia IGS Pulse angiographic X-ray system Class II 2026-04-20 Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including Class II 2026-01-30 Allia Moveo angiographic X-ray system Class II 2026-04-20 Allia IGS 5 Pulse angiographic X-ray system Class II 2026-04-20 Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 Class II 2026-03-26 Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (inclu Class II 2026-01-30 Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 Class II 2026-03-26 Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including Class II 2026-01-30 Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 Class II 2026-03-26 Allia IGS 7 Pulse angiographic X-ray system Class II 2026-04-20 Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 Class II 2026-03-26 GE Signa Artist, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy Class II 2025-03-21 GE HealthCare OEC 9900 Elite C-arm Systems. Class II 2025-07-02 GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE Signa Voyager, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535 Class II 2025-09-18 Optima XR646 HD. X-Ray imaging system. Class II 2025-01-28 GE HealthCare OEC 9800. Class II 2025-07-02 GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 SIGNA Architect Class II 2025-05-23 Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system. Class II 2025-01-28 GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H Class II 2025-03-06 GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 SIGNA Architect AIR Class II 2025-05-23 GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed Class II 2025-02-18 GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 Discovery XR656 HD. X-Ray imaging system. Class II 2025-01-28 GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance Class II 2025-06-20 MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu Class II 2025-08-22 GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed Class II 2025-02-18 GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE Healthcare Revolution CT, System, X-ray, Tomography, Computed Class II 2025-02-18 GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 Class II 2025-09-18 Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography Class II 2025-10-24 GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed Class II 2025-02-18 SIGNA PET/MR Class II 2025-05-23 GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed Class II 2025-02-18 GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 LOGIQ P10 series with software version R4.5.7 Model Number 5877534 Class II 2025-09-18 GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed Class II 2025-02-18 Discovery MR750w 3.0T Class II 2025-05-23 GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 OEC 3D Class II 2025-03-21 Discovery XR656HD. X-Ray imaging system. Class II 2025-01-28 GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system Class II 2025-03-06 GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed Class II 2025-02-18 GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System Class II 2025-06-20 Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO Class II 2024-11-18 SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Ima Class II 2024-06-14 Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV Class II 2024-11-18 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, Class II 2024-06-14 GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) Class II 2024-11-25 GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) Class II 2024-11-25 SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System Class II 2024-06-14 SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emi Class II 2024-06-14 Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imagi Class II 2024-06-14 SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magne Class II 2024-06-14 Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syste Class II 2024-06-14 Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Class II 2024-12-06 SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on Class II 2024-06-14 SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System Class II 2024-10-28 SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System Class II 2024-06-14 SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System Class II 2024-06-14 Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Ma Class II 2024-06-14 SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nucle Class II 2024-06-14 Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1 Class II 2024-06-14 SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System Class II 2024-06-14 Discovery MR750w 3.0T, whole body magnetic resonance scanner Class II 2024-10-28 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16 Class II 2024-06-14 SIGNA Architect, Nuclear Magnetic Resonance Imaging System Class II 2024-10-28 GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3 Class II 2024-11-25 SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System Class II 2024-06-14 Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only Class II 2024-06-14 SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonan Class II 2024-06-14 SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Class II 2024-06-14 SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Mag Class II 2024-06-14 SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use Class II 2024-06-14 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30 Class II 2024-06-14 Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610 Class II 2024-11-18 Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO Class II 2024-11-18 SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System Class II 2024-06-14 Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVER Class II 2024-10-28 Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV Class II 2024-11-18 SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR3 Class II 2024-06-14 Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30. Class II 2024-06-14 Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Class II 2024-06-14
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.