Device Recall GE Discovery ST PET/CT

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA