GE Medical Systems, LLC recalls GE Healthcare Optima XR240amx, Mobile Digital Radiographic S

Hazard / Issue

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

Issued by

FDA

Distribution: Worldwide

Lot/Code Info: 1) 5555000-27: UDI/DI 840682122351, Serial Numbers: 228867XR240, 252847PP241, 281274OPT1, 281338CL240, 281VHVXR240, 305682DIG1, 305682DIG3, 305KEN240B, 401OPTI2, 405949OPT1, 408559XRDR7, 413447OPT1, 419251OPT, 419690DP1, 504842XR242, 602344240A, 602344MARY240, 713440DP2, 713440DP3, 720854DF1, 732222DP3, 763520XR10, 763520XRA6, 806725OPT, 865305DP1, 941276XRA, 970495OPTI1, 973926OPT1, BOLDWPACPORT02, GLEDWPACPORT02, HMHWT240P5, LIHOPTIMA240B, OCHSNERWB240, SAMC240A; 2) 5555000-31: UDI/DI 840682122351, Serial Numbers: 00158MOB17, DF2401800221WK, U416249MOB240; 3) 5555000-33: UDI/DI 840682122351, Serial Numbers: 082407100689, 228867XR240C; 4) 5555000-41: UDI/DI 840682122351, Serial Numbers: 00130MOB16, 5973XR0225, DEF11034, RS4025RX05, SA1058MM50; 5) 5555000-47: UDI/DI 840682122351, Serial Numbers: 206223OPTIMA1, 206248OPT2, 206341OPT2402, 212838OPTIMA1, 219326AMX2, 256HHPORT5, 256HHPORT6, 260824XR240, 270793OPT, 270793OPT1, 304256OPTIMA240, 307324XR240, 318626OPX240FP, 336716WFP2, 336716WFP3, 404616OPT2, 405657OPT, 406345OPT1, 406653XR240, 406653XRA1, 414266XR243, 423837X240, 425228OPT240, 435713OPX240, 435789XR240, 502897M241, 504842OPTFP1, 504894XR244, 513952OPT1, 530888OPT2, 541789M3, 551996DIG1, 706527OPT2, 712662OPT240, 713440DP4, 718918XR240B, 785623OPT2, 786308XR240, 801465XR240, 805652M2, 816943XR240A, 828369OPT1, 850864FWDH240, 865977DP2, 901595XRA1, 914787XR2401, 916781OPT4, 951788XR240P2, 954723XR240B, 972596OPT3, 973877OPT1, AMX240GEN2SYSTEM17, AMX240GEN2SYSTEM9, HMHXR240P7, KAFB228OPTIMA2, LNMCDP1, LVCCER240B, MBMCPORTD; 6) A0700DL: UDI/DI 840682122351, Serial Numbers: 082407250223; 7) A1700DA: UDI/DI 840682122351, Serial Numbers: 210METM2, 256543OPT, 337261OPT, 360744OPT2402, 425899OPT, 425SNORIDGE, 509946AMX1, 573814DP8, 574231OPT2, 702852OPT, 850864FWDH2401, HMHXR240P1, OMCTOPT1; 8) To be provided: UDI/DI To be provided, Serial Numbers: 256543OPT1, 405657FP1417, 513952OPT2, RU1018RX04.