← Every firm
GE Medical Systems, LLC FDA Recalls
124 recalls on file across devices, 0 of them Class I and 124 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Optima XR240amx, Mobile Digital Radiographic SystemClass IIJun 5, 2026GE HealthCare has become aware that in certain Optima XR200/ |
| Optima XR200amx, Mobile Digital-Ready Radiographic SystemClass IIJun 5, 2026GE HealthCare has become aware that in certain Optima XR200/ |
| Optima XR220amx, Mobile Digital-Ready Radiographic SystemClass IIJun 5, 2026GE HealthCare has become aware that in certain Optima XR200/ |
| Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500Class IIMay 1, 2026GE HealthCare has become aware of a potential issue involvin |
| Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warClass IIMay 1, 2026GE HealthCare has become aware of a potential issue involvin |
| Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All ModelsClass IIMay 1, 2026GE HealthCare has become aware of a potential issue involvin |
| Allia IGS Pulse angiographic X-ray systemClass IIApr 20, 2026GE HealthCare has become aware of a potential issue affectin |
| Allia IGS 5 Pulse angiographic X-ray systemClass IIApr 20, 2026GE HealthCare has become aware of a potential issue affectin |
| Allia IGS 3 Pulse angiographic X-ray systemClass IIApr 20, 2026GE HealthCare has become aware of a potential issue affectin |
| Allia IGS 7 Pulse angiographic X-ray systemClass IIApr 20, 2026GE HealthCare has become aware of a potential issue affectin |
| Allia Moveo angiographic X-ray systemClass IIApr 20, 2026GE HealthCare has become aware of a potential issue affectin |
| Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27Class IIMar 26, 2026GE HealthCare has become aware of a potential security vulne |
| Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23Class IIMar 26, 2026GE HealthCare has become aware of a potential security vulne |
| Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15Class IIMar 26, 2026GE HealthCare has become aware of a potential security vulne |
| Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6Class IIMar 26, 2026GE HealthCare has become aware of a potential security vulne |
| Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20Class IIMar 26, 2026GE HealthCare has become aware of a potential security vulne |
| Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25Class IIMar 26, 2026GE HealthCare has become aware of a potential security vulne |
| Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300Class IIMar 26, 2026GE HealthCare has become aware of a potential security vulne |
| Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8Class IIFeb 3, 2026There is a potential issue that can lead to discordance betw |
| Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including Class IIJan 30, 2026There is a potential cybersecurity vulnerability affecting c |
| Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (incluClass IIJan 30, 2026There is a potential cybersecurity vulnerability affecting c |
| Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (includingClass IIJan 30, 2026There is a potential cybersecurity vulnerability affecting c |
| Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammographyClass IIOct 24, 2025Some Senographe Pristina systems either have a missing or an |
| LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533Class IISep 18, 2025The Ultrasound-Guided Attenuation Parameter (UGAP) measureme |
| LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535Class IISep 18, 2025The Ultrasound-Guided Attenuation Parameter (UGAP) measureme |
| LOGIQ P10 series with software version R4.5.7 Model Number 5877534Class IISep 18, 2025The Ultrasound-Guided Attenuation Parameter (UGAP) measureme |
| MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model NuClass IIAug 22, 2025If a user incorrectly places the Acquisition Module into the |
| GE HealthCare OEC 9800.Class IIJul 2, 2025GE HealthCare has become aware of a non-conformance to 21 CF |
| GE HealthCare OEC 9900 Elite C-arm Systems.Class IIJul 2, 2025GE HealthCare has become aware of a non-conformance to 21 CF |
| GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE Signa Artist, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic ResonanceClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE Signa Voyager, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Hero, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Architect, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Premier, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA UHP, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging SystemClass IIJun 20, 2025GE HealthCare has become aware that for certain MR systems ( |
| SIGNA ArchitectClass IIMay 23, 2025GE HealthCare has become aware that gradient coils for certa |
| SIGNA PET/MRClass IIMay 23, 2025GE HealthCare has become aware that gradient coils for certa |
| Discovery MR750w 3.0TClass IIMay 23, 2025GE HealthCare has become aware that gradient coils for certa |
| SIGNA Architect AIRClass IIMay 23, 2025GE HealthCare has become aware that gradient coils for certa |
| OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomyClass IIMar 21, 2025OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Im |
| OEC 3DClass IIMar 21, 2025OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Im |
| Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 systemClass IIMar 6, 2025The battery for certain ultrasound systems can potentially d |
| Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers HClass IIMar 6, 2025The battery for certain ultrasound systems can potentially d |
| GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, ComputedClass IIFeb 18, 2025GE HealthCare has become aware of a potential issue on certa |
| GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, ComputedClass IIFeb 18, 2025GE HealthCare has become aware of a potential issue on certa |
| GE Healthcare Revolution CT ES, System, X-ray, Tomography, ComputedClass IIFeb 18, 2025GE HealthCare has become aware of a potential issue on certa |
| GE Healthcare Revolution Apex, System, X-ray, Tomography, ComputedClass IIFeb 18, 2025GE HealthCare has become aware of a potential issue on certa |
| GE Healthcare Revolution CT, System, X-ray, Tomography, ComputedClass IIFeb 18, 2025GE HealthCare has become aware of a potential issue on certa |
| GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, ComputedClass IIFeb 18, 2025GE HealthCare has become aware of a potential issue on certa |
| GE Healthcare Revolution Apex Select, System, X-ray, Tomography, ComputedClass IIFeb 18, 2025GE HealthCare has become aware of a potential issue on certa |
| Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.Class IIJan 28, 2025The user can continue to take the next exposure after reachi |
| Discovery XR656HD. X-Ray imaging system.Class IIJan 28, 2025The user can continue to take the next exposure after reachi |
| Discovery XR656 HD. X-Ray imaging system.Class IIJan 28, 2025The user can continue to take the next exposure after reachi |
| Optima XR646 HD. X-Ray imaging system.Class IIJan 28, 2025The user can continue to take the next exposure after reachi |
| Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Class IIDec 6, 2024There is a software issue that can result in the loss of pat |
| GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3Class IINov 25, 2024GE HealthCare has become aware that in certain Optima XR200/ |
| GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3)Class IINov 25, 2024GE HealthCare has become aware that in certain Optima XR200/ |
| GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) Class IINov 25, 2024GE HealthCare has become aware that in certain Optima XR200/ |
| Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610Class IINov 18, 2024Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 |
| Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISOClass IINov 18, 2024Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 |
| Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISOClass IINov 18, 2024Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 |
| Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEVClass IINov 18, 2024Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 |
| Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEVClass IINov 18, 2024Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 |
| SIGNA Architect, Nuclear Magnetic Resonance Imaging SystemClass IIOct 28, 2024Gradient coils for certain MR systems (see affected product |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERClass IIOct 28, 2024Gradient coils for certain MR systems (see affected product |
| Discovery MR750w 3.0T, whole body magnetic resonance scannerClass IIOct 28, 2024Gradient coils for certain MR systems (see affected product |
| SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging SystemClass IIOct 28, 2024Gradient coils for certain MR systems (see affected product |
| SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging SystemClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emiClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use onClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging SystemClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance ImagiClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic ResonanClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance ImaClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30Class IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging SystemClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging SystemClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16Class IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear MagneClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear MaClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging SystemClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging SysteClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research useClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; NucleClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1Class IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging SystemClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR3Class IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| 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 IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging SystemClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging SystemClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| 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 IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use onlyClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear MagClass IIJun 14, 2024GE HealthCare has become aware that for certain MR systems, |
| B125P Patient Monitor (with E-module slot option), REF 6160000-002Class IINov 16, 2022GE Healthcare has become aware that if certain B1x5P / B1x5M |
| B125M Patient Monitor, REF 6160000-005-XXXXXXXClass IINov 16, 2022GE Healthcare has become aware that if certain B1x5P / B1x5M |
| B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,Class IINov 16, 2022GE Healthcare has become aware that if certain B1x5P / B1x5M |
| B125M Patient Monitor, REF 6160000-004-XXXXXXClass IINov 16, 2022GE Healthcare has become aware that if certain B1x5P / B1x5M |
| B105M Patient Monitor, REF 6160000-003Class IINov 16, 2022GE Healthcare has become aware that if certain B1x5P / B1x5M |
| Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062).Class IINov 10, 2022Potential for batteries that have not been replaced at 2 yea |
| Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small OClass IINov 10, 2022Potential for batteries that have not been replaced at 2 yea |
| Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small OClass IINov 10, 2022Potential for batteries that have not been replaced at 2 yea |
| Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; AbdominaClass IINov 10, 2022Potential for batteries that have not been replaced at 2 yea |
| Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small OrClass IINov 10, 2022Potential for batteries that have not been replaced at 2 yea |
| Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; AbdominaClass IINov 10, 2022Potential for batteries that have not been replaced at 2 yea |
| Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; AbdominalClass IINov 10, 2022Potential for batteries that have not been replaced at 2 yea |
| Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; AbdominClass IINov 10, 2022Potential for batteries that have not been replaced at 2 yea |
| Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaginClass IIOct 28, 2022There is the potential that after installation of the IAS to |
| Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and datClass IIOct 28, 2022There is the potential that after installation of the IAS to |