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Ge Medical Systems Israel, Functional Imaging FDA Recalls
41 recalls on file across devices, 6 of them Class I and 40 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni LegenClass IIDec 24, 2025There is a potential intermittent issue on certain Omni Lege |
| MAXXUS, System, Tomography, Computed, EmissionClass IIDec 10, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| SMV DSX New Line, System, Tomography, Computed, EmissionClass IIDec 10, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| SMV BodyTrack, System, Tomography, Computed, EmissionClass IIDec 10, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| SMV DSI, System, Tomography, Computed, EmissionClass IIDec 10, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically foClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingClass IISep 12, 2025GE HealthCare has become aware that certain Nuclear Medicine |
| Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine systemClass IIJun 20, 2025Unintended radial detector motion may occur during patient s |
| Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine SystemClass IIJun 20, 2025Unintended radial detector motion may occur during patient s |
| GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, EmissionClass IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, EmissionClass IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H31Class IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001Class IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CClass IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, TomograClass IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography,Class IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5)Class IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, EmissionClass IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, EmissionClass IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3Class IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, ComClass IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5Class IIDec 18, 2024GE HealthCare has become aware that certain Infinia, VariCam |
| MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (Class IIApr 15, 2024There is a potential issue regarding the service handles for |
| GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, Class IDec 19, 2022A mitigation may not be correctly implemented. If this is th |
| GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 86Class IDec 19, 2022A mitigation may not be correctly implemented. If this is th |
| GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, Class IDec 19, 2022A mitigation may not be correctly implemented. If this is th |
| GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, Class IDec 19, 2022A mitigation may not be correctly implemented. If this is th |
| GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20,Class IDec 19, 2022A mitigation may not be correctly implemented. If this is th |
| GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, Class IDec 19, 2022A mitigation may not be correctly implemented. If this is th |