GE Medical Systems, LLC
GE Medical Systems, LLC appears in FDA public data with 168 recalls, 328 510(k) clearances, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2726-2026, Class II) was initiated on June 5, 2026. Its most recent 510(k) clearance was granted on June 24, 2026.
Summary
- Total Recalls
- 168
- 510(k) Clearances
- 328
- Inspections
- 11
- Compliance Actions
- 0
Known Names
ge medical systems, ge medical systems information technologies, ge medical systems israel, functional imaging, ge medical systems ultrasound and primary care diagnostics, ll, ge medical systems ultrasound and primary care diagn
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2726-2026 | Class II | Optima XR200amx, Mobile Digital-Ready Radiographic System | June 5, 2026 |
| Z-2728-2026 | Class II | Optima XR240amx, Mobile Digital Radiographic System | June 5, 2026 |
| Z-2727-2026 | Class II | Optima XR220amx, Mobile Digital-Ready Radiographic System | June 5, 2026 |
| Z-2475-2026 | Class II | Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models | May 1, 2026 |
| Z-2477-2026 | Class II | Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500 | May 1, 2026 |
| Z-2476-2026 | Class II | Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubat | May 1, 2026 |
| Z-2314-2026 | Class II | Allia IGS 3 Pulse angiographic X-ray system | April 20, 2026 |
| Z-2316-2026 | Class II | Allia IGS 7 Pulse angiographic X-ray system | April 20, 2026 |
| Z-2317-2026 | Class II | Allia IGS Pulse angiographic X-ray system | April 20, 2026 |
| Z-2318-2026 | Class II | Allia Moveo angiographic X-ray system | April 20, 2026 |
| Z-2315-2026 | Class II | Allia IGS 5 Pulse angiographic X-ray system | April 20, 2026 |
| Z-2150-2026 | Class II | Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 | March 26, 2026 |
| Z-2155-2026 | Class II | Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 | March 26, 2026 |
| Z-2152-2026 | Class II | Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 | March 26, 2026 |
| Z-2149-2026 | Class II | Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 | March 26, 2026 |
| Z-2154-2026 | Class II | Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 | March 26, 2026 |
| Z-2151-2026 | Class II | Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 | March 26, 2026 |
| Z-2153-2026 | Class II | Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 | March 26, 2026 |
| Z-1590-2026 | Class II | Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Num | February 3, 2026 |
| Z-1570-2026 | Class II | Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medic | January 30, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253560 | Enhanced Boundary for PCCT | June 24, 2026 |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | April 14, 2026 |
| K253520 | Photonova Spectra, Photonova Spectra Select | March 20, 2026 |
| 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 |