ProductGuru Recalls

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GE Medical Systems, LLC: official recall notices

62 official recall or safety notices on this site name GE Medical Systems, LLC, dated between 2024-06-14 and 2026-06-05. They were issued by 1 authority: US FDA — Medical Devices (62).

Countries where the notices were issued: United States (62).

Name as written in the notices: GE Medical Systems, LLC. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.

Notices by year

YearNotices
202617
202526
202419

Notices by authority

AuthorityNotices
US FDA — Medical Devices62

All notices

DateAuthorityProductHazard (as classified)
2026-06-05US FDA — Medical DevicesOptima XR200amx, Mobile Digital-Ready Radiographic System—
2026-06-05US FDA — Medical DevicesOptima XR220amx, Mobile Digital-Ready Radiographic System—
2026-06-05US FDA — Medical DevicesOptima XR240amx, Mobile Digital Radiographic System—
2026-05-01US FDA — Medical DevicesGiraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500—
2026-05-01US FDA — Medical DevicesGiraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models—
2026-05-01US FDA — Medical DevicesGiraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant war—
2026-04-20US FDA — Medical DevicesAllia IGS 3 Pulse angiographic X-ray system—
2026-04-20US FDA — Medical DevicesAllia IGS Pulse angiographic X-ray system—
2026-04-20US FDA — Medical DevicesAllia Moveo angiographic X-ray system—
2026-04-20US FDA — Medical DevicesAllia IGS 5 Pulse angiographic X-ray system—
2026-04-20US FDA — Medical DevicesAllia IGS 7 Pulse angiographic X-ray system—
2026-03-26US FDA — Medical DevicesRevolution CT ES, X-ray Computed Tomography, Model Number 5590000-15—
2026-03-26US FDA — Medical DevicesRevolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300—
2026-03-26US FDA — Medical DevicesRevolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27—
2026-03-26US FDA — Medical DevicesRevolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23—
2026-01-30US FDA — Medical DevicesCentricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including—
2026-01-30US FDA — Medical DevicesCentricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (inclu—
2025-08-22US FDA — Medical DevicesMAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu—
2025-07-02US FDA — Medical DevicesGE HealthCare OEC 9900 Elite C-arm Systems.—
2025-07-02US FDA — Medical DevicesGE HealthCare OEC 9800.—
2025-06-20US FDA — Medical DevicesGE Signa Artist, Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE Signa Voyager, Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance—
2025-06-20US FDA — Medical DevicesGE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System—
2025-06-20US FDA — Medical DevicesGE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System—
2025-05-23US FDA — Medical DevicesSIGNA Architect—
2025-05-23US FDA — Medical DevicesSIGNA Architect AIR—
2025-02-18US FDA — Medical DevicesGE Healthcare Revolution Apex, System, X-ray, Tomography, Computed—
2025-02-18US FDA — Medical DevicesGE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed—
2025-02-18US FDA — Medical DevicesGE Healthcare Revolution CT, System, X-ray, Tomography, Computed—
2025-01-28US FDA — Medical DevicesOptima XR646 HD. X-Ray imaging system.—
2025-01-28US FDA — Medical DevicesDefinium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.—
2025-01-28US FDA — Medical DevicesDiscovery XR656 HD. X-Ray imaging system.—
2024-11-25US FDA — Medical DevicesGE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3)—
2024-11-25US FDA — Medical DevicesGE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3)—
2024-11-25US FDA — Medical DevicesGE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3—
2024-06-14US FDA — Medical DevicesSIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Ima—
2024-06-14US FDA — Medical DevicesSIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1,—
2024-06-14US FDA — Medical DevicesSIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System—
2024-06-14US FDA — Medical DevicesSIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emi—
2024-06-14US FDA — Medical DevicesDiscovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imagi—
2024-06-14US FDA — Medical DevicesSIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magne—
2024-06-14US FDA — Medical DevicesOptima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syste—
2024-06-14US FDA — Medical DevicesSIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on—
2024-06-14US FDA — Medical DevicesSIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System—
2024-06-14US FDA — Medical DevicesSIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System—
2024-06-14US FDA — Medical DevicesOptima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Ma—
2024-06-14US FDA — Medical DevicesSIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nucle—
2024-06-14US FDA — Medical DevicesDiscovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1—
2024-06-14US FDA — Medical DevicesSIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System—
2024-06-14US FDA — Medical Devices3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16—
2024-06-14US FDA — Medical DevicesSIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System—

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