Ge Medical Systems Israel, Functional Imaging
Ge Medical Systems Israel, Functional Imaging holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2025, with 41 FDA device recalls on record.
Top product codes for Ge Medical Systems Israel, Functional Imaging
FDA recalls by Ge Medical Systems Israel, Functional Imaging
10 most recent of 41- Z-1112-2026 — GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
- Z-1045-2026 — SMV DSI, System, Tomography, Computed, Emission
- Z-1047-2026 — MAXXUS, System, Tomography, Computed, Emission
- Z-1044-2026 — SMV DSX New Line, System, Tomography, Computed, Emission
- Z-1046-2026 — SMV BodyTrack, System, Tomography, Computed, Emission
- Z-0299-2026 — Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Z-0291-2026 — Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Z-0295-2026 — Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Z-0296-2026 — Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Z-0302-2026 — Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ge Medical Systems Israel, Functional Imaging
Data sourced from openFDA. This site is unofficial and independent of the FDA.