GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission

Hazard

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.

Details from the source

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: 430 units Lot/code info: 1) H3100JZ: UDI/DI N/A, System ID UAB640, Serial Number 26139/25146; UDI/DI N/A, System ID 479441N640, Serial Number 26150/25152; UDI/DI N/A, System ID 480BAY640, Serial Number 26195/25195; UDI/DI N/A, System ID 602UACC640, Serial Number 26191/25189; UDI/DI N/A, System ID 520VA640, Serial Number 26329/640V25328; UDI/DI N/A, System ID 530756OPT1, Serial Number ONMW26439/640W25433; UDI/DI N/A, System ID 626359D640, Serial Number 26109/25111; UDI/DI N/A, System ID 858824NM640, Serial Number 26221/25222; UDI/DI N/A, System ID 909558NM640, Serial Number 26297/640V25296; UDI/DI N/A, System ID 949364D640, Serial Number ONMW26437/640W25432; UDI/DI N/A, System ID 510437O640, Serial Number 26199/25203; UDI/DI N/A, System ID 714456OPT1, Serial Number ONMX26520/640X25513; UDI/DI N/A, System ID 916973OPT1, Serial Number ONMW26426/640W25422; UDI/DI N/A, System ID 619543NM640, Serial Number 26281/25276; UDI/DI N/A, System ID 415300OPTIMA, Serial Number ONMX26481/640X25475; UDI/DI N/A, System ID 415353D640, Serial Number 26149/25115; UDI/DI N/A, System ID 415221NM640 , Serial Number ONMY26475/640Y25556; UDI/DI N/A, System ID 408559O640, Serial Number ONMX26529/640X25522; UDI/DI N/A, System ID 650742OPTIMA, Serial Number ONMX26518/640X25509; UDI/DI N/A, System ID 209476OPT1, Serial Number 26338/640V25337; UDI/DI N/A, System ID 310222NM640, Serial Number ONMW26418/640W25413; UDI/DI N/A, System ID 707554OPT1, Serial Number 26140/25145; UDI/DI N/A, System ID 303695NM1, Serial Number ONMW26436/64

UPC codes

83140260432, 83150352409, 83144792014, 83140257832, 83119337412, 83181910698, 83140748318, 83148555730, 83136619674, 082426040071, 082426040067, 082426040069, 082426220011, 082426040077, 082426160055, 082426140037, 082426160058, 082426180001, 082426210026, 082426210031, 082426120041, 83026000349815, 83026800008113

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.