Device Recall Pentax Video Duodenoscope

  • Modelo / Serial
    Model Numbers: Ed-3490TK and ED-3270K
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
  • Descripción del producto
    Video Duodenoscope || These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    All Serial Numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District of Columbia.
  • Descripción del producto
    Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) || These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.
  • Manufacturer