Ge Medical Systems Israel, Functional Imaging recalls
7 official recalls and safety alerts involving Ge Medical Systems Israel, Functional Imaging since 2023-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Ge Medical Systems Israel, Functional Imaging or the relevant agency.
- 2026-01-28
USGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni…
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil,…Official notice →- 2026-01-21
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls SMV DSI, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGUS, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France,…Official notice → - 2025-10-29
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in…
- 2025-07-16
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide - US Nationwide distribution.Official notice → - 2025-01-22
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography,…
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)…
- 2024-06-19
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac…
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…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice → - 2023-02-15
- US
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…
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide distribution. US nationwide including Puerto Rico, Algeria,…Official notice →