GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

Worldwide Distribution-USA (nationwide) including the states of AL, CO, FL, IN, KS, KY, MN, NC, OH, TX, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BULGARIA, CANADA, CHINA, ABIDJAN COTEDIVOIRE EGYPT, FRANCE, GERMANY, GREAT BRITAIN, INDIA, IRAQ, ITALY, JAPAN, KENYA, LATVIA, LEBANON, MALAYSIA, MARTINIQUE,MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, PORTUGAL ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and VIETNAM.

Lote

Mfg Lot or Serial # System ID 00000311096HM2 561747CT2 00000317657HM5 859313TCCT 00000318100HM5 765447CDICT 00000320796HM6 317569CDINE 00000322703HM0 317846CDINCT 00000323060HM4 651294OPT 00000325273HM1 317890CDIS 00000325782HM1 317890CDIW 00000325783HM9 INSIGHTCT2013 00000326335HM7 Unknown 00000328883HM4 606573O540 00000330505HM9 972596CT540 00000331902HM7 651294OPT 00000333256HM6 Unknown 00000336763HM8 620384CT 00000337348HM7 850325OPT540 00000338324HM7 251275GHCTOP540 00000338344HM5 419ARROWCT 00000339268HM5 817465PORT 00000339269HM3 571367OP540 00000339708HM0 980212CT 00000340245HM0 704403NCRC 00000340698HM0 TMCACT540 00000341570HM0 620257CT540 00000341573HM4 Unknown 00000342027HM0 620234CT 00000342972HM7 Unknown 00000343769HM6 Unknown 00000344605HM1 419PERRYCT 00000300762HM2 DZ1061CT02 00000308967HM9 DZ1460CT01 00000310027HM8 DZ1466CT01 00000310562HM4 DZ1070CT03 00000311872HM6 DZ1481CT01 00000311873HM4 DZ1255CT01 00000313494HM7 DZ1476CT01 00000318960HM2 DZ1551CT01 00000326325HM8 DZ1482CT02 00000326888HM5 DZ1404CT01 00000332418HM3 DZ1526CT01 00000304142HM3 0910213163 00000307762HM5 0910213164 00000318131HM0 0910212230 00000320782HM6 0910212233 00000328111HM0 0910212233 00000328289HM4 Unknown 00000329547HM4 Unknown 00000333910HM8 83094749135 00000336762HM0 83093534693 00000340201HM3 83093282036 00000340648HM5 Unknown 00000344608HM5 Unknown 00000345259HM6 Unknown 00000304667HM9 030079CT01 00000326872HM9 030173CT04 00000314578HM6 BG4646CT01 00000336118HM5 BG4657CT01 00000332406HM8 416756BSCT 00000335739HM9 Unknown 00000339713HM0 Unknown 00000308344HM1 CI1048CT02 00000310563HM2 CI1065CT01 00000327491HM7 CI1070CT01 00000313495HM4 EG1924CT01 00000333231HM9 EG1925CT01 00000304668HM7 X180869704 00000304669HM5 M6044523 00000306538HM0 M9164621 00000307761HM7 M4216031 00000310043HM5 P4200409 00000310044HM3 M171587014 00000310045HM0 M1118326 00000314580HM2 M156048204 00000315893HM8 M4472517 00000316785HM5 X4180101 00000319320HM8 M4465308 00000319974HM2 Unknown 00000327492HM5 Unknown 00000330901HM0 X25010006 00000331618HM9 X268338801 00000331769HM0 M4476206 00000333921HM5 M2862815 00000334370HM4 Unknown 00000335056HM8 M4190909 00000335057HM6 B1303711 00000335740HM7 B1648607 00000335749HM8 B2397706 00000336112HM8 X90281608 00000336113HM6 X751962014 00000336740HM6 M2035139 00000336741HM4 Unknown 00000337349HM5 L1650215 00000337350HM3 A6036412 00000337351HM1 M4168612 00000338321HM3 M226077905 00000338322HM1 F1500419 00000338323HM9 F1680831 00000339265HM1 X751968023 00000339266HM9 M8322907 00000339707HM2 M180384809 00000340244HM3 A2032118 00000340246HM8 M151671015 00000340247HM6 A6039713 00000340695HM6 M6013310 00000340696HM4 M9185628 00000340697HM2 X874019008 00000341571HM8 M2399410 00000341572HM6 Unknown 00000341614HM6 Unknown 00000342028HM8 Unknown 00000342042HM9 M2311408 00000342043HM7 M4166654 00000342970HM1 M4202009 00000342971HM9 Unknown 00000343741HM5 Unknown 00000343742HM3 Unknown 00000343767HM0 Unknown 00000343768HM8 Unknown 00000344607HM7 Unknown 00000344616HM8 Unknown 00000345262HM0 Unknown 00000290194HM0 X255095203 00000292644HM2 782203CT01 00000296062HM3 695382CT01 00000299346HM7 PC6686CT01 00000303916HM1 PC5606CT01 00000305394HM9 509940CT01 00000308345HM8 PC4318CT03 00000312758HM6 826251CT01 00000312760HM2 PC9940CT01 00000314579HM4 HC7669CT03 00000314581HM0 543871CT02 00000315066HM1 HC0285CT01 00000316797HM0 387171CT01 00000317429HM9 387171CT01 00000318129HM4 409208CT01 00000319973HM4 409208CT01 00000325252HM5 Unknown 00000326326HM6 HC0953CT03 00000327482HM6 HC7137CT02 00000328740HM6 PC7343CT01 00000328741HM4 PC0252CT01 00000329531HM8 CC7137CT02 00000330485HM4 CC1990CT01 00000330895HM4 HC1172CT02 00000332417HM5 PC0976CT01 00000335099HM8 CC1543CT02 00000336100HM3 Unknown 00000339274HM3 Unknown 00000339695HM9 Unknown 00000339697HM5 Unknown 00000340645HM1 Unknown 00000341615HM3

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States