Events

Recall of SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE

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
    15176
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-07
  • 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
    Changes to the instructions for the leak test method specified for all fujifilm endoscopes in the cleaning disinfection and storage operation manuals as well as the operation manuals for the air leak tester lt-7f were made to ensure consistency with the iso 8600-7 standard. specific requirements added were to conduct the submersion test for the duration of at least one minute and using a water temperature range of 10 degrees celsius to 40 degrees celsius.

Device

SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE
  • Model / Serial
    Model Catalog: ALL (Lot serial: ALL)
  • Product Description
    SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - GASTROSCOPE;SIGMOIDSCOPE;COLONOSCOPE EC;SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - BRONCHOSCOPE;DOUBLE BALLOON METHOD ELECTRONIC ENTEROSCOPY SYSTEM - ENTEROSCOPE;SERIES 200 ELECTRONIC VIDEO ENDOSCOPE SYST
  • Manufacturer
    VANTAGE ENDOSCOPY INC.

Manufacturer

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