Device Recall GE Discovery ST PET/CT

  • Modelo / Serial
    617243PETCT, 203688DST, ALLIANCEPETCT30, 203863DST, 973989DST, 908979DST, 212535DST, 412942DST, 814366CTPET, 202715PTCT, 443663DST, 850863FWPET, 863680DST, 251343DST, 832237EHDST, 0002584305, 574535PET, 763257DST, DMSIPCO7, EPHCPASRW1, 801408DST, 949417DST, 406255PET, 805546CT1, 415222CL1, 503692PETCT, 360SALPET, 425228DST, 402390DST1, 201996DST, AH4001PE01, 2558941, 082445040002, 082445160009, 082445160006, 082445160010, 514340DST, 423468PE01, 10495DST01, A4194408, 10094PTM70, 00060DST01, 00060DST02, A5138110, C5123618, A5215931, A99263302, A5111228, A5808512, A5279305, A5645908, YE0010, YE0009, 81DST2547033, ZWL0470, PER10934, 732292DST, ALLIANCEPCT41, DMSIPC15, 763463PC14, ALLIANCEPETCT28, ALLIANCEPETCT29, 972867DST, 082445040003, 2585577DISCPET, A5645911, YE0100, YE0113, YE0404, YE0403, 0834450002, 787269PETCT, 0002592878
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Worldwide. AL, CA, CT, FL, IN, MA, MD, MN, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, Puerto Rico. OUS to include: Austria, Brazil, Canada, China, Columbia, Egypt, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, United Kingdom, Venezuela
  • Descripción del producto
    Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT with high performance PET that is optimized for routine 2D and 3D oncology, cardiology and neurology clinical studies.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA