Device Recall Innova 2100IQ with InnovaIQ Table Option

  • Modèle / numéro de série
    00000553797BU2, 00000000075WV2, 00000000112WV3, 00000000153WV7, 00000000146WV1, 00000000023WV2, 00000000162WV8, 00000000079WV4, 00000000149WV5, and 00000000033WV1.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.
  • Description du dispositif
    Innova 2100IQ system with InnovaIQ Table Option || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, || rotational imaging procedures.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ge Healthcare, Llc, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
  • Source
    USFDA