Device Recall Innova 3100/ 3100IQ with InnovaIQ Table Option

  • Modelo / Serial
    00000008C20323, 00000519107BU7, 00000007C20116, 00000464098BU3, - 00000000057WV0, 00000000086WV9, 00000000130WV5, 00000000050WV5, 00000000083WV6, 00000000193WV3, 00000000203WV0, and  00000000076WV0.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    Innova 3100/ 3100IQ 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

Fabricante

  • Dirección del fabricante
    Ge Healthcare, Llc, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA