Events

Recall of DUODENOVIDEOSCOPE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OLYMPUS CANADA 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
    26945
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-25
  • 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
    Olympus is conducting a recall of certain serial numbers of tjf-q180v duodenoscopes that were repaired by olympus canada inc. the purpose of this action is to inspect for and correct as necessary a potential quality issue associated with the application of adhesive to the distal end tip during the previous repair work for these tjf-q180v duodenoscopes. this action is limited exclusively to repairs done by olympus canada inc. for specific serial numbers.

Device

DUODENOVIDEOSCOPE
  • Model / Serial
    Model Catalog: TJF-Q180V (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    DUODENOVIDEOSCOPE
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.