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GE Medical Systems, LLC

FDA Regulatory Profile

Summary

Total Recalls
150
510(k) Clearances
327
Inspections
11
Compliance Actions
0

Known Names

ge medical systems, ge medical systems ultrasound and primary care diagnostics, ll, ge medical systems information technologies, ge medical systems israel, functional imaging, ge medical systems ultrasound and primary care diagn

Recent Recalls

NumberClassProductDate
Z-1590-2026Class IIImactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model NumFebruary 3, 2026
Z-1569-2026Class IICentricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medicaJanuary 30, 2026
Z-1571-2026Class IICentricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays mJanuary 30, 2026
Z-1570-2026Class IICentricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medicJanuary 30, 2026
Z-0875-2026Class IISenographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammograOctober 24, 2025
Z-0157-2026Class IILOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533September 18, 2025
Z-0155-2026Class IILOGIQ P10 series with software version R4.5.7 Model Number 5877534September 18, 2025
Z-0156-2026Class IILOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535September 18, 2025
Z-0231-2026Class IIMAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocAugust 22, 2025
Z-2341-2025Class IIGE HealthCare OEC 9800.July 2, 2025
Z-2342-2025Class IIGE HealthCare OEC 9900 Elite C-arm Systems.July 2, 2025
Z-2308-2025Class IIGE SIGNA Hero, Nuclear Magnetic Resonance Imaging SystemJune 20, 2025
Z-2317-2025Class IIGE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging SystemJune 20, 2025
Z-2304-2025Class IIGE SIGNA Premier, Nuclear Magnetic Resonance Imaging SystemJune 20, 2025
Z-2300-2025Class IIGE Signa Voyager, Nuclear Magnetic Resonance Imaging SystemJune 20, 2025
Z-2315-2025Class IIGE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging SystemJune 20, 2025
Z-2320-2025Class IIGE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging SystemJune 20, 2025
Z-2311-2025Class IIGE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging SystemJune 20, 2025
Z-2319-2025Class IIGE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging SystemJune 20, 2025
Z-2314-2025Class IIGE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging SystemJune 20, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmApril 14, 2026
K253520Photonova Spectra, Photonova Spectra SelectMarch 20, 2026
K253780SIGNA™ BoltFebruary 6, 2026
K253779SIGNA™ Sprint SelectFebruary 5, 2026
K252379AIR Recon DLDecember 23, 2025
K251399SIGNA™ SprintSeptember 11, 2025
K250941Revolution VibeAugust 1, 2025
K243667Sonic DLJune 5, 2025
K250379SIGNA Prime EliteMarch 17, 2025
K241242SIGNA MAGNUSOctober 17, 2024
K233750ECG-less CardiacApril 2, 2024
K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical CareMay 25, 2023
K230082Auto SegmentationMay 4, 2023
K223514Spectral Bone MarrowMarch 9, 2023
K220848Venue FitJune 27, 2022
K220851VenueJune 27, 2022
K213999Deep Learning Image ReconstructionFebruary 18, 2022
K213709SIGNA PET/MRJanuary 20, 2022
K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; December 17, 2021
K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmOctober 29, 2021