Events

Recall of SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - VIDEO MODULES

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
    15090
  • Event Risk Class
    III
  • Event Initiated Date
    2015-08-21
  • 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 that the epx-2500 operation manual and sales brochure incorrectly identify that the ed-530xt endoscope is capable of being used with the epx- 2500 processor. the operation manual and sales brochure state that when the ed- 530xt endoscope is used with the 2500 processor a "super image" is displayed when it is actually a "standard image" that is displayed.

Device

SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - VIDEO MODULES
  • Model / Serial
    Model Catalog: EPX-2500 (Lot serial: 202B1230408E or earlier)
  • Product Description
    SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM
  • Manufacturer
    VANTAGE ENDOSCOPY INC.

Manufacturer

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