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: 93 units Lot/code info: 1) H3000WN: UDI/DI N/A, System ID YN1593, Serial Number 16433. 2) H3000YM: UDI/DI N/A, System ID 602406INF, Serial Number 16012; UDI/DI N/A, System ID 928537INF, Serial Number 16021; UDI/DI N/A, System ID 661633NM1, Serial Number 15013; UDI/DI N/A, System ID 661633NM1, Serial Number 16051; UDI/DI N/A, System ID 619482INFINIA, Serial Number 16007; UDI/DI N/A, System ID 626359INF2, Serial Number 16175; UDI/DI N/A, System ID 626359INF1, Serial Number 16177; UDI/DI N/A, System ID 916983INFN1, Serial Number 16059; UDI/DI N/A, System ID 858554INF1, Serial Number 16169; UDI/DI N/A, System ID 858554INF2, Serial Number 16186; UDI/DI N/A, System ID 626570INF1, Serial Number 16030; UDI/DI N/A, System ID 310543INF1, Serial Number 16006; UDI/DI N/A, System ID 303320IH, Serial Number 16013; UDI/DI N/A, System ID 860350INIF, Serial Number 16065; UDI/DI N/A, System ID 863687INF1, Serial Number 16182; UDI/DI N/A, System ID 941629INF, Serial Number 16026; UDI/DI N/A, System ID 630801INF, Serial Number 16054; UDI/DI N/A, System ID 316962WI, Serial Number 16048; UDI/DI N/A, System ID 270651INF1, Serial Number 16002; UDI/DI N/A, System ID 225765INF1, Serial Number 16070; UDI/DI N/A, System ID 318681INFINIA, Serial Number 16033; UDI/DI N/A, System ID 508828INF, Serial Number 16173; UDI/DI N/A, System ID 906776INF, Serial Number 16001; UDI/DI N/A, System ID 989723INF1, Serial Number 16050; UDI/DI N/A, System ID 989723INF2, Serial Number 16073; UDI/DI N/A, System ID 919934INF, Serial Number 16099; U
082426200003, 082426090016, 082426160026, 83026602101643, 85150299222, 82426130041
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.