Events

Recall of PINPOINT ENDOSCOPIC FLUORESCENCE IMAGING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NOVADAQ TECHNOLOGIES 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
    114615
  • Event Risk Class
    I
  • Event Initiated Date
    2016-02-02
  • 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
    Operator manual is being recalled since it does not contain validated parameters for gravity-cycle autoclave sterilization of the pinpoint laparoscopes and light guide cable in the reprocessing tray.

Device

PINPOINT ENDOSCOPIC FLUORESCENCE IMAGING SYSTEM

Manufacturer

NOVADAQ TECHNOLOGIES INC.
  • Manufacturer Address
    BURNABY
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC