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.
Reason for recall: 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. Distribution: Worldwide Quantity: 877 units Lot/code info: 1) H2799ZP: UDI/DI N/A, System ID A5109665, Serial Number 16611; 2) H3000WT: UDI/DI N/A, System ID 205408NUC, Serial Number 17419; UDI/DI N/A, System ID 256341NRM1, Serial Number 18226; UDI/DI N/A, System ID 256494NM1, Serial Number 17133; UDI/DI N/A, System ID 256543INF1, Serial Number 17182; UDI/DI N/A, System ID 205408INF2, Serial Number 18157; UDI/DI N/A, System ID 256429INF1, Serial Number 17557; UDI/DI N/A, System ID 256327NUC, Serial Number 17900; UDI/DI N/A, System ID 334418INF, Serial Number 17266; UDI/DI N/A, System ID 256386HKNM2, Serial Number 16970; UDI/DI N/A, System ID 205750INF, Serial Number 16802; UDI/DI N/A, System ID 501776INF, Serial Number 17294; UDI/DI N/A, System ID 479463INF2, Serial Number 16900; UDI/DI N/A, System ID 501202INF, Serial Number 16564; UDI/DI N/A, System ID 479967INF, Serial Number 16817; UDI/DI N/A, System ID 479549INF, Serial Number 18319; UDI/DI N/A, System ID 479751INF, Serial Number 16800; UDI/DI N/A, System ID 928214INF, Serial Number 17075; UDI/DI N/A, System ID 520868INF, Serial Number 18289; UDI/DI N/A, System ID 602588INF, Serial Number 17054; UDI/DI N/A, System ID 623406INF1, Serial Number 17064; UDI/DI N/A, System ID 480512INF2, Serial Number 18250; UDI/DI N/A, System ID 623478NM2, Serial Number 16223; UDI/DI N/A, System ID 602406INF, Serial Number 17739; UDI/DI N/A, System ID 602406OPINF, Serial Number 17746; UDI/DI N/A, System ID 480324INF, Serial Number 17150; UDI/DI N/A, System ID 480323INFRM2, Serial Number 17584; UDI/D
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Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.