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GE Medical Systems, LLC

215 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Optima XR200amx, Mobile Digital-Ready Radiographic System recall (Z-2726-2026)GE Medical Systems, LLC2026-07-13
Optima XR220amx, Mobile Digital-Ready Radiographic System recall (Z-2727-2026)GE Medical Systems, LLC2026-07-13
Optima XR240amx, Mobile Digital Radiographic System recall (Z-2728-2026)GE Medical Systems, LLC2026-07-13
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models recall (Z-2475-2026)GE Medical Systems, LLC2026-06-17
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infa recall (Z-2476-2026)GE Medical Systems, LLC2026-06-17
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-50 recall (Z-2477-2026)GE Medical Systems, LLC2026-06-17
Allia IGS 3 Pulse angiographic X-ray system recall (Z-2314-2026)GE Medical Systems, LLC2026-06-05
Allia IGS 5 Pulse angiographic X-ray system recall (Z-2315-2026)GE Medical Systems, LLC2026-06-05
Allia IGS 7 Pulse angiographic X-ray system recall (Z-2316-2026)GE Medical Systems, LLC2026-06-05
Allia IGS Pulse angiographic X-ray system recall (Z-2317-2026)GE Medical Systems, LLC2026-06-05
Allia Moveo angiographic X-ray system recall (Z-2318-2026)GE Medical Systems, LLC2026-06-05
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 recall (Z-2149-2026)GE Medical Systems, LLC2026-05-08
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 recall (Z-2150-2026)GE Medical Systems, LLC2026-05-08
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 recall (Z-2151-2026)GE Medical Systems, LLC2026-05-08
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 recall (Z-2152-2026)GE Medical Systems, LLC2026-05-08
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 recall (Z-2153-2026)GE Medical Systems, LLC2026-05-08
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 recall (Z-2154-2026)GE Medical Systems, LLC2026-05-08
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 recall (Z-2155-2026)GE Medical Systems, LLC2026-05-08
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, recall (Z-1590-2026)GE Medical Systems, LLC2026-03-20
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displ recall (Z-1569-2026)GE Medical Systems, LLC2026-03-16
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that disp recall (Z-1570-2026)GE Medical Systems, LLC2026-03-16
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that recall (Z-1571-2026)GE Medical Systems, LLC2026-03-16
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic recall (Z-0875-2026)GE Medical Systems, LLC2025-12-09
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel restin recall (Z-0231-2026)GE Medical Systems, LLC2025-10-22
LOGIQ P10 series with software version R4.5.7 Model Number 5877534 recall (Z-0155-2026)GE Medical Systems, LLC2025-10-15
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 587 recall (Z-0156-2026)GE Medical Systems, LLC2025-10-15
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 recall (Z-0157-2026)GE Medical Systems, LLC2025-10-15
GE HealthCare OEC 9800. recall (Z-2341-2025)GE Medical Systems, LLC2025-08-22
GE HealthCare OEC 9900 Elite C-arm Systems. recall (Z-2342-2025)GE Medical Systems, LLC2025-08-22
GE Signa Artist, Nuclear Magnetic Resonance Imaging System recall (Z-2299-2025)GE Medical Systems, LLC2025-08-13
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System recall (Z-2300-2025)GE Medical Systems, LLC2025-08-13
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System recall (Z-2301-2025)GE Medical Systems, LLC2025-08-13
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System recall (Z-2302-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System recall (Z-2303-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System recall (Z-2304-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System recall (Z-2305-2025)GE Medical Systems, LLC2025-08-13
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System recall (Z-2306-2025)GE Medical Systems, LLC2025-08-13
GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System recall (Z-2307-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System recall (Z-2308-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Ma recall (Z-2309-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System recall (Z-2310-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2311-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2312-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2313-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2314-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2315-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2316-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2317-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2318-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2319-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System recall (Z-2320-2025)GE Medical Systems, LLC2025-08-13
SIGNA Architect recall (Z-2130-2025)GE Medical Systems, LLC2025-07-18
SIGNA Architect AIR recall (Z-2131-2025)GE Medical Systems, LLC2025-07-18
Discovery MR750w 3.0T recall (Z-2132-2025)GE Medical Systems, LLC2025-07-18
SIGNA PET/MR recall (Z-2133-2025)GE Medical Systems, LLC2025-07-18
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot recall (Z-1819-2025)GE Medical Systems, LLC2025-06-09
OEC 3D recall (Z-1820-2025)GE Medical Systems, LLC2025-06-09
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number recall (Z-1555-2025)GE Medical Systems, LLC2025-04-11
Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H4 recall (Z-1556-2025)GE Medical Systems, LLC2025-04-11
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed recall (Z-1297-2025)GE Medical Systems, LLC2025-03-07
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed recall (Z-1298-2025)GE Medical Systems, LLC2025-03-07
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed recall (Z-1299-2025)GE Medical Systems, LLC2025-03-07
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed recall (Z-1300-2025)GE Medical Systems, LLC2025-03-07
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed recall (Z-1301-2025)GE Medical Systems, LLC2025-03-07
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed recall (Z-1302-2025)GE Medical Systems, LLC2025-03-07
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed recall (Z-1303-2025)GE Medical Systems, LLC2025-03-07
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709) recall (Z-1043-2025)GE Medical Systems, LLC2025-02-03
Discovery XR656HD. X-Ray imaging system. recall (Z-1044-2025)GE Medical Systems, LLC2025-02-03
Discovery XR656 HD. X-Ray imaging system. recall (Z-1045-2025)GE Medical Systems, LLC2025-02-03
Optima XR646 HD. X-Ray imaging system. recall (Z-1046-2025)GE Medical Systems, LLC2025-02-03
Portrait Core Services, a set of software services that enable the communication and inter recall (Z-0918-2025)GE Medical Systems, LLC2025-01-15
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 55550 recall (Z-0811-2025)GE Medical Systems, LLC2025-01-07
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 55550 recall (Z-0812-2025)GE Medical Systems, LLC2025-01-07
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 55550 recall (Z-0813-2025)GE Medical Systems, LLC2025-01-07
Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603 recall (Z-0814-2025)GE Medical Systems, LLC2025-01-07
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO recall (Z-0815-2025)GE Medical Systems, LLC2025-01-07
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV recall (Z-0816-2025)GE Medical Systems, LLC2025-01-07
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO recall (Z-0817-2025)GE Medical Systems, LLC2025-01-07
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV recall (Z-0818-2025)GE Medical Systems, LLC2025-01-07
Discovery MR750w 3.0T, whole body magnetic resonance scanner recall (Z-0517-2025)GE Medical Systems, LLC2024-11-22
SIGNA Architect, Nuclear Magnetic Resonance Imaging System recall (Z-0518-2025)GE Medical Systems, LLC2024-11-22
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System recall (Z-0519-2025)GE Medical Systems, LLC2024-11-22
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: recall (Z-0520-2025)GE Medical Systems, LLC2024-11-22
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28 recall (Z-2459-2024)GE Medical Systems, LLC2024-08-02
SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 t recall (Z-2460-2024)GE Medical Systems, LLC2024-08-02
SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Reso recall (Z-2461-2024)GE Medical Systems, LLC2024-08-02
SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2 recall (Z-2462-2024)GE Medical Systems, LLC2024-08-02
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 recall (Z-2463-2024)GE Medical Systems, LLC2024-08-02
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to D recall (Z-2464-2024)GE Medical Systems, LLC2024-08-02
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to recall (Z-2465-2024)GE Medical Systems, LLC2024-08-02
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tom recall (Z-2466-2024)GE Medical Systems, LLC2024-08-02
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuc recall (Z-2467-2024)GE Medical Systems, LLC2024-08-02
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29. recall (Z-2468-2024)GE Medical Systems, LLC2024-08-02
SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR3 recall (Z-2469-2024)GE Medical Systems, LLC2024-08-02
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, recall (Z-2470-2024)GE Medical Systems, LLC2024-08-02
1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, recall (Z-2471-2024)GE Medical Systems, LLC2024-08-02
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, recall (Z-2472-2024)GE Medical Systems, LLC2024-08-02
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; N recall (Z-2473-2024)GE Medical Systems, LLC2024-08-02
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance I recall (Z-2474-2024)GE Medical Systems, LLC2024-08-02
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance I recall (Z-2475-2024)GE Medical Systems, LLC2024-08-02
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