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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Recalls
41 recalls on record · February 15, 2023 to January 28, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401C
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Com
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
January 22, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomogra
Hazard: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
June 19, 2024Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (
Hazard: There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.
February 15, 2023Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 86
Hazard: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
February 15, 2023Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm,
Hazard: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
February 15, 2023Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch,
Hazard: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
February 15, 2023Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch,
Hazard: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
February 15, 2023Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20,
Hazard: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
February 15, 2023Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA,
Hazard: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.