FDA recall record · openFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
35 FDA recalls on record (2024–2025) — 35 device. 35 still ongoing.
0
Class I (most serious)
35
Class II
0
Class III
35
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could h 14
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, 13
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein 4
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct 2
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PE 1
Recalls
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legen Class II 2025-12-24 Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically fo Class II 2025-09-12 Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 SMV DSI, System, Tomography, Computed, Emission Class II 2025-12-10 Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system Class II 2025-06-20 Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 SMV BodyTrack, System, Tomography, Computed, Emission Class II 2025-12-10 Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 SMV DSX New Line, System, Tomography, Computed, Emission Class II 2025-12-10 MAXXUS, System, Tomography, Computed, Emission Class II 2025-12-10 Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System Class II 2025-06-20 Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Class II 2025-09-12 GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Com Class II 2024-12-18 GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomogra Class II 2024-12-18 GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission Class II 2024-12-18 GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H31 Class II 2024-12-18 GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission Class II 2024-12-18 GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401C Class II 2024-12-18 GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Class II 2024-12-18 GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission Class II 2024-12-18 GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission Class II 2024-12-18 GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) Class II 2024-12-18 GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5 Class II 2024-12-18 GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3 Class II 2024-12-18 MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT ( Class II 2024-04-15 GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001 Class II 2024-12-18
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.