GE Medical Systems, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 146
- 510(k) Clearances
- 325
- Inspections
- 11
- Compliance Actions
- 0
Known Names
ge medical systems, ge medical systems information technologies, ge medical systems ultrasound and primary care diagnostics, ll, ge medical systems israel, functional imaging, ge medical systems ultrasound and primary care diagn
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0875-2026 | Class II | Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammogra | October 24, 2025 |
| Z-0155-2026 | Class II | LOGIQ P10 series with software version R4.5.7 Model Number 5877534 | September 18, 2025 |
| Z-0156-2026 | Class II | LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535 | September 18, 2025 |
| Z-0157-2026 | Class II | LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 | September 18, 2025 |
| Z-0231-2026 | Class II | MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electroc | August 22, 2025 |
| Z-2341-2025 | Class II | GE HealthCare OEC 9800. | July 2, 2025 |
| Z-2342-2025 | Class II | GE HealthCare OEC 9900 Elite C-arm Systems. | July 2, 2025 |
| Z-2312-2025 | Class II | GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2320-2025 | Class II | GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2311-2025 | Class II | GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2319-2025 | Class II | GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2316-2025 | Class II | GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2305-2025 | Class II | GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2304-2025 | Class II | GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2317-2025 | Class II | GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2300-2025 | Class II | GE Signa Voyager, Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2314-2025 | Class II | GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2302-2025 | Class II | GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2299-2025 | Class II | GE Signa Artist, Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
| Z-2306-2025 | Class II | GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System | June 20, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253780 | SIGNA Bolt | February 6, 2026 |
| K253779 | SIGNA Sprint Select | February 5, 2026 |
| K252379 | AIR Recon DL | December 23, 2025 |
| K251399 | SIGNA Sprint | September 11, 2025 |
| K250941 | Revolution Vibe | August 1, 2025 |
| K243667 | Sonic DL | June 5, 2025 |
| K250379 | SIGNA Prime Elite | March 17, 2025 |
| K241242 | SIGNA MAGNUS | October 17, 2024 |
| K233750 | ECG-less Cardiac | April 2, 2024 |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care | May 25, 2023 |
| K230082 | Auto Segmentation | May 4, 2023 |
| K223514 | Spectral Bone Marrow | March 9, 2023 |
| K220848 | Venue Fit | June 27, 2022 |
| K220851 | Venue | June 27, 2022 |
| K213999 | Deep Learning Image Reconstruction | February 18, 2022 |
| K213709 | SIGNA PET/MR | January 20, 2022 |
| K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; | December 17, 2021 |
| K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | October 29, 2021 |
| K211846 | Discovery MI Gen2 | August 20, 2021 |
| K211118 | SIGNA 7.0T | May 13, 2021 |