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: 859 units Lot/code info: 1) 5376204-70-54-2: UDI/DI N/A, System ID NT1030, Serial Number T27G16017/ 133897HL9; UDI/DI N/A, System ID NT4004, Serial Number T27G15008/ 128542HL8; UDI/DI N/A, System ID NT4008, Serial Number T27G16019/ 134674HL1; UDI/DI N/A, System ID NT4007, Serial Number T27G16018/ 134286HL4; UDI/DI N/A, System ID NT4009, Serial Number T27G16016/ 133646HL0; UDI/DI N/A, System ID NT1021, Serial Number T27G1700031/ 147750HL4; UDI/DI N/A, System ID NT4010, Serial Number T27G16020/ 134675HL8; UDI/DI N/A, System ID NT4012, Serial Number T27G1700032/ 148489HL8; UDI/DI N/A, System ID NT4001, Serial Number T27G15002/ 122818HL8; UDI/DI N/A, System ID NT4006, Serial Number T27G15013/ 131436HL8; UDI/DI N/A, System ID NT4002, Serial Number T27G15003/ 124423HL5; UDI/DI N/A, System ID NT4013, Serial Number T27G1700035/ 151334HL0. 2) H2401BC: UDI/DI N/A, System ID 83163862277, Serial Number T2EG1700003/153301HL7; UDI/DI N/A, System ID 83103685384, Serial Number T2AG13029/141BH2; UDI/DI N/A, System ID 83095572309, Serial Number T2AG13023/132BH1; UDI/DI N/A, System ID 83095060278, Serial Number T2AG13025/100091HL8; UDI/DI N/A, System ID 83154010867, Serial Number T2EG1600002/0; UDI/DI N/A, System ID 83091096402, Serial Number T2DG13001/133BH9; UDI/DI N/A, System ID 0910265076, Serial Number T2AG12006/86884HL4; UDI/DI N/A, System ID 0910263259, Serial Number T2AG12010/103BH2; UDI/DI N/A, System ID 0910263259, Serial Number T2AG12014/103BH2; UDI/DI N/A, System ID NT1014, Serial Number T2AG13024/134BH7; U
83163862277, 83103685384, 83095572309, 83095060278, 83154010867, 83091096402, 840682121187, 082426310032, 082426110014, 082426040073, 082426040064, 082426040063, 082426220009, 082426040065, 082426040070, 082426220012, 082426110013, 082426160050, 082426140034, 082426010019, 082426130046, 082426160051, 082426100068, 082426100063, 082426150037, 082426160046, 082426160049, 082426160053, 082426160047, 082426170005, 082426070043, 082426070040, 082426010020, 082426010023, 082426010022, 082426090040, 082426210027, 082426210022, 082426060011, 082426060013
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.