GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW

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: 845 units Lot/code info: 1) H2799PP: UDI/DI N/A, System ID 850260060, Serial Number 16130. 2) H2799PR: UDI/DI N/A, System ID 217347INF2, Serial Number 17325. 3) H2799YC: UDI/DI N/A, System ID M54606103, Serial Number 16846. 4) H2799YD: UDI/DI N/A, System ID M348992912, Serial Number 17033. 5) H3000WC: UDI/DI N/A, System ID 907562HK4, Serial Number 18610; UDI/DI N/A, System ID 907562HK4, Serial Number 18643; UDI/DI N/A, System ID 205783INF1, Serial Number 17571; UDI/DI N/A, System ID 479553INF, Serial Number 18470; UDI/DI N/A, System ID 479441INF1, Serial Number 17301; UDI/DI N/A, System ID 928855INF, Serial Number 17190; UDI/DI N/A, System ID 480512INF1, Serial Number 17019; UDI/DI N/A, System ID 602406INF1, Serial Number 18422; UDI/DI N/A, System ID 602406INF3, Serial Number 18465; UDI/DI N/A, System ID 480323INFRM3, Serial Number 17488; UDI/DI N/A, System ID 480882INF1, Serial Number 18026; UDI/DI N/A, System ID 530888IN1, Serial Number 18579; UDI/DI N/A, System ID 760873NUC, Serial Number 17290; UDI/DI N/A, System ID 6502IN1, Serial Number 17680; UDI/DI N/A, System ID 916537IN2, Serial Number 17264; UDI/DI N/A, System ID 510537IN1, Serial Number 18280; UDI/DI N/A, System ID 626915INF1, Serial Number 16946; UDI/DI N/A, System ID 209223IN, Serial Number 18308; UDI/DI N/A, System ID 559353IN, Serial Number 17995; UDI/DI N/A, System ID 626573INF1, Serial Number 17410; UDI/DI N/A, System ID 510400IN, Serial Number 17108; UDI/DI N/A, System ID 530533IN, Serial Number 18531; UDI/DI N/A, System ID 916782I

UPC codes

082426110009, 082426040039, 082426040055, 082426040060, 082426040050, 082426190015, 082426200009, 082426100062, 082426020007, 082426200010, 082426130035, 082426130032, 082426160034, 082426180012, 082426180013, 082426090018, 082426210016, 082426200007, 082426100040, 082426100033, 082426100037, 82426230024, 83026600020711, 082426110008, 082426110011, 082426040049, 082426040042, 082426040058, 082426040051, 082426040066, 082426040041, 082426190024, 082426020005, 082426160037, 082426140019, 082426140024, 082426110006, 082426070024, 082426200004, 082426180010

Source

Official record: FDA (Device enforcement) ↗

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