GE Medical Systems, LLC
94 recalls on record · Latest: Dec 17, 2025
FDA Devices Moderate Dec 17, 2025
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
FDA Devices Moderate Oct 29, 2025
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Cod…
FDA Devices Moderate Oct 22, 2025
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
FDA Devices Moderate Oct 22, 2025
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
FDA Devices Moderate Sep 3, 2025
GE HealthCare OEC 9900 Elite C-arm Systems.
FDA Devices Moderate Sep 3, 2025
GE HealthCare OEC 9800.
FDA Devices Moderate Aug 20, 2025
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
FDA Devices Moderate Aug 20, 2025
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 20, 2025
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Jul 30, 2025
SIGNA Architect
FDA Devices Moderate Jul 30, 2025
SIGNA Architect AIR
FDA Devices Moderate Jun 18, 2025
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/device…
FDA Devices Moderate Apr 23, 2025
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surge…
FDA Devices Moderate Mar 19, 2025
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
FDA Devices Moderate Mar 19, 2025
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
FDA Devices Moderate Mar 19, 2025
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
FDA Devices Moderate Feb 12, 2025
Optima XR646 HD. X-Ray imaging system.
FDA Devices Moderate Feb 12, 2025
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
FDA Devices Moderate Feb 12, 2025
Discovery XR656 HD. X-Ray imaging system.
FDA Devices Moderate Jan 22, 2025
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution component…
FDA Devices Moderate Jan 15, 2025
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
FDA Devices Moderate Jan 15, 2025
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
FDA Devices Moderate Jan 15, 2025
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5…
FDA Devices Moderate Jan 15, 2025
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
FDA Devices Moderate Jan 15, 2025
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-4…
FDA Devices Moderate Dec 4, 2024
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Dec 4, 2024
Discovery MR750w 3.0T, whole body magnetic resonance scanner
FDA Devices Moderate Dec 4, 2024
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 14, 2024
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 14, 2024
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, DV29.2, MR30.0, MR30.1; Nucl…
FDA Devices Moderate Aug 14, 2024
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 14, 2024
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography wit…
FDA Devices Moderate Aug 14, 2024
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 14, 2024
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 14, 2024
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 14, 2024
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
FDA Devices Moderate Aug 14, 2024
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Aug 14, 2024