medical Class II Updated 2025-01-22

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Varicam Millennium VG Discovery VH, Model/Cata

Recalled Product

GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission

Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: 1) ASM000085: UDI/DI N/A, System ID NM10569, Serial Number 10569; UDI/DI N/A, System ID NM10570, Serial Number 10570; UDI/DI N/A, System ID YN0845, Serial Number 10242; UDI/DI N/A, System ID YN0498, Serial Number 1092; UDI/DI N/A, System ID YN0440, Serial Number 1003; UDI/DI N/A, System ID 979764VGH1, Serial Number 77521848; UDI/DI N/A, System ID NM10225, Serial Number 10225. 2) ASM001092: UDI/DI N/A, System ID 310231VGH1, Serial Number 10539; UDI/DI N/A, System ID 207795VH, Serial Number 10571; UDI/DI N/A, System ID 82426070015, Serial Number 10550; UDI/DI N/A, System ID 82426210010, Serial Number 10595; UDI/DI N/A, System ID 82426280001, Serial Number 10591; UDI/DI N/A, System ID 082426080009, Serial Number 10599; UDI/DI N/A, System ID H2103NUC06, Serial Number 10582; UDI/DI N/A, System ID H1404NUC06, Serial Number 10604; UDI/DI N/A, System ID H2094NUC07, Serial Number 10587; UDI/DI N/A, System ID YN0984, Serial Number 10543; UDI/DI N/A, System ID 850260054, Serial Number 10579; UDI/DI N/A, System ID RU1591NM01, Serial Number 10561; UDI/DI N/A, System ID RU1457NM01, Serial Number 10553; UDI/DI N/A, System ID 209526MILVG, Serial Number 10340; UDI/DI N/A, System ID 416469DVH, Serial Number 10384; UDI/DI N/A, System ID CY1088MN04, Serial Number 10360; UDI/DI N/A, System ID Not Available, Serial Number 81251648; UDI/DI N/A, System ID B5315325, Serial Number 10185. 3) ASM001099: UDI/DI N/A, System ID PER10925, Serial Number 10346. 4) SYS000001: UDI/DI N/A, System ID NM10374, Serial Number 10374; UDI/DI N/A, System ID NM10147, Serial Number 10147; UDI/DI N/A, System ID 334794MILVG, Serial Number 1063; UDI/DI N/A, System ID NM10291, Serial number 10291; UDI/DI N/A, System ID 56948, Serial number 1021. 5) SYS000002: UDI/DI N/A, System ID 949760VG1, Serial Number 10445; UDI/DI N/A, System ID NM10174, Serial Number 10174; UDI/DI N/A, System ID 223410MILVG, Serial Number 1069. 6) SYS000003: UDI/DI N/A, System ID 914734VG, Serial number 10435.
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