GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emi

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: 704 units Lot/code info: 1) 5376204-30-2: UDI/DI N/A, System ID NT3058, Serial Number T2BG1600023/ 146187HL0; UDI/DI N/A, System ID NT3061, Serial Number T2BG1600029/ 147600HL1; UDI/DI N/A, System ID NT3111, Serial Number 147243HL0; UDI/DI N/A, System ID NT3072, Serial Number 151822HL4; UDI/DI N/A, System ID NT3081, Serial Number T2BG1700045/ 155928HL5; UDI/DI N/A, System ID NT3080, Serial Number T2BG1700042/ 155272HL8; UDI/DI N/A, System ID NT3098, Serial Number T2BG1700051/ 158839HL1; UDI/DI N/A, System ID NT3088, Serial Number T2BG1700048/ 157050HL6; UDI/DI N/A, System ID NT3073, Serial Number T2BG1700040/ 150067HL7; UDI/DI N/A, System ID NT3076, Serial Number 153537HL6; UDI/DI N/A, System ID NT3048, Serial Number 141262HL6; UDI/DI N/A, System ID NT3083, Serial Number T2BG1700049/ 158144HL6; UDI/DI N/A, System ID NT0003, Serial Number T2AG14033/ 108281HL7; UDI/DI N/A, System ID NT3064, Serial Number T2BG1600025/ 146380HL1; UDI/DI N/A, System ID NT3082, Serial Number T2BG1700047/ 156900HL3; UDI/DI N/A, System ID NT3057, Serial Number T2BG1600022/ 146064HL1; UDI/DI N/A, System ID NT0005, Serial Number T2AG14040/ 119081HL8; UDI/DI N/A, System ID NT3054, Serial Number T2BG1600019/ 144873HL7; UDI/DI N/A, System ID NT3070, Serial Number T2BG1600024/ 146363HL7; UDI/DI N/A, System ID NT3067, Serial Number T2BG1600031/ 148143HL1; UDI/DI N/A, System ID NT3068, Serial Number T2BG1600034/ 149490HL5; UDI/DI N/A, System ID NT3063, Serial Number T2BG1600030/ 147951HL8; UDI/DI N/A, System ID NT3062, Serial Number

UPC codes

83178091150, 84068212376, 00840682115292

Source

Official record: FDA (Device enforcement) ↗

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