GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING appears in FDA public data with 41 recalls — including 6 Class I (most serious) —, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1112-2026, Class II) was initiated on December 24, 2025. Its most recent 510(k) clearance was granted on January 17, 2025.
Summary
- Total Recalls
- 41 (6 Class I)
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1112-2026 | Class II | GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI L | December 24, 2025 |
| Z-1044-2026 | Class II | SMV DSX New Line, System, Tomography, Computed, Emission | December 10, 2025 |
| Z-1045-2026 | Class II | SMV DSI, System, Tomography, Computed, Emission | December 10, 2025 |
| Z-1046-2026 | Class II | SMV BodyTrack, System, Tomography, Computed, Emission | December 10, 2025 |
| Z-1047-2026 | Class II | MAXXUS, System, Tomography, Computed, Emission | December 10, 2025 |
| Z-0297-2026 | Class II | Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0295-2026 | Class II | Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0299-2026 | Class II | Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0301-2026 | Class II | Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0292-2026 | Class II | Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0294-2026 | Class II | Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0303-2026 | Class II | Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0300-2026 | Class II | Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0296-2026 | Class II | Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0293-2026 | Class II | Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0290-2026 | Class II | Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-0302-2026 | Class II | Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera desi | September 12, 2025 |
| Z-0298-2026 | Class II | Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imagin | September 12, 2025 |
| Z-0291-2026 | Class II | Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | September 12, 2025 |
| Z-2097-2025 | Class II | Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system | June 20, 2025 |