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: 116 units Lot/code info: 1) 5376204-15: UDI/DI 00840682145503, System ID 502629NMGD, Serial Number NT2UG2100002BH; UDI/DI 00840682117869, System ID 509455BRIVO, Serial Number NT24G1700010BH, UDI/DI N/A, System ID 248544D630, Serial Number NT2QG1900003BH\NT2UG2100001BH. 2) H2401MA: UDI/DI Not Available, System ID 501552D615, Serial Number NT24G1600023; UDI/DI Not Available, System ID 100035454149, Serial Number T2CG15015/100035454149; UDI/DI Not Available, System ID 337643NM, Serial Number NT24G1600021; UDI/DI Not Available, System ID 718963B615, Serial Number NT24G1700009; UDI/DI Not Available, System ID Not Available, Serial Number NT24G1600020; UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1700010; UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1800001; UDI/DI (01)00840682117869(11)17060021NT24G1700003BH, System ID NM6583AR, Serial Number NT24G1700003; UDI/DI (01)00840682117869(11)17090021NT24G1700006BH, System ID NT24G1700006BH, Serial Number NT24G1700006; UDI/DI (01)00840682117869(11)17080021NT24G1700004BH, System ID NT24G1700004BH, Serial Number NT24G1700004; UDI/DI Not Available, System ID Not Available, Serial Number NT24G1700008; UDI/DI Not Available, System ID CS1052NM10, Serial Number T2CG15010/166BH9; UDI/DI Not Available, System ID DK1043NM01, Serial Number T2CG15009/163BH6; UDI/DI Not Available, System ID EG2559NM01, Serial Number NT24G1700001; UDI/DI Not Available, System ID M4143529, Serial Number T2CG16018/187BH5; UDI/DI Not Available, System ID 0830
00840682145503, 00840682117869, 100035454149, 082426100061
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.