FDAFDA · Alimentos y medicamentos·N.º oficial Z-0889-2025
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
Publicado el 22 de enero de 2025 · Inicio del retiro: 18 de diciembre de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Distribuidor
- Worldwide
- Lote
- 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 083026108252217, Serial Number T2CG16019/232BH9; UDI/DI Not Available, System ID 083026108252217, Serial Number NT24G1700005; UDI/DI Not Available, System ID 083026861420919, Serial Number NT24G1800007; UDI/DI Not Available, System ID Not Available, Serial Number T2CG13006/127BH1; UDI/DI Not Available, System ID 083026862894721, Serial Number NT24G1800005; UDI/DI Not Available, System ID 083026861823315, Serial Number T2CG15014/177BH6; UDI/DI Not Available, System ID 083026208602217, Serial Number NT24G1700002/227BH9; UDI/DI Not Available, System ID 083026285354315, Serial Number T2CG15013/176BH8; UDI/DI Not Available, System ID 083026040018413, Serial Number T2CG12003/116BH4; UDI/DI Not Available, System ID Not Available, Serial Number T2CG11002; UDI/DI Not Available, System ID Not Available, Serial Number T2CG12004; UDI/DI Not Available, System ID Not Available, Serial Number T2CG14007; UDI/DI Not Available, System ID PK1267NM01, Serial Number T2CG11001/84BH4; UDI/DI Not Available, System ID 1557MI0001, Serial Number T2CG15012/170BH1; UDI/DI Not Available, System ID SA2514NM01, Serial Number NT24G1600022; UDI/DI Not Available, System ID ZA2757NM01, Serial Number T2CG16016/182BH6; UDI/DI (01)00840682117869(11)171100NT24G1700007BH, System ID ZA3066NM01, Serial Number NT24G1700007; UDI/DI Not Available, System ID ZA2223NM02, Serial Number T2CG15008/161BH0; UDI/DI Not Available, System ID ZA3209NM01, Serial Number NT24G1800003; UDI/DI Not Available, System ID 475290NU02, Serial Number NT24G1800002; UDI/DI Not Available, System ID 266340NU01, Serial Number T2CG16017/185BH9. 3) H3100TA: UDI/DI N/A, System ID 478765BRIVO1, Serial Number 24003; UDI/DI N/A, System ID 515239MGB615, Serial Number 24022; UDI/DI N/A, System ID 606242B615, Serial Number 24018; UDI/DI N/A, System ID 859879B615, Serial Number 24053; UDI/DI N/A, System ID 337788BR615, Serial Number 24035; UDI/DI N/A, System ID 248898B615, Serial Number 24056; UDI/DI N/A, System ID 651241DSC615, Serial Number 24037; UDI/DI N/A, System ID 406222LN615, Serial Number 24001; UDI/DI N/A, System ID B615GEMINI01, Serial Number 24058; UDI/DI N/A, System ID Not Available, Serial Number 24052; UDI/DI N/A, System ID 702304NM615, Serial Number 24013; UDI/DI N/A, System ID 607762B615, Serial Number 24030; UDI/DI N/A, System ID 513636B615, Serial Number 24059; UDI/DI N/A, System ID 937208B615, Serial Number 24070; UDI/DI N/A, System ID 405456NM615, Serial Number 24004; UDI/DI N/A, System ID 806665NM615, Serial Nu
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Israel
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