Events

Recall of SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VANTAGE ENDOSCOPY INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    39152
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Fujifilm has become aware of events in which the suction button on the ed-530xt endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ercp procedures. the contrast agent gets sticky and can solidify upon drying causing the suction button to become lodged.

Device

SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE
  • Model / Serial
    Model Catalog: ED-530XT (Lot serial: >10 contact manufacturer)
  • Product Description
    SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE
  • Manufacturer
    VANTAGE ENDOSCOPY INC.

Manufacturer

VANTAGE ENDOSCOPY INC.
  • Manufacturer Address
    KITCHENER
  • Manufacturer Parent Company (2017)
    Diploma Plc
  • Source
    HC