Events

Recall of IMPAX FOR CARDIOLOGY - CLINICAL REVIEW STATION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGFA HEALTHCARE 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
    15069
  • Event Risk Class
    II
  • Event Initiated Date
    2012-01-26
  • 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
    Agfa has determined that the current process allowing changes to be made to the impax cv reporting application content via rmat has the potential for misuse. errors may result from uncontrolled changes and these errors could lead to incorrect and clinically significant inaccuracies in the report.

Device

IMPAX FOR CARDIOLOGY - CLINICAL REVIEW STATION
  • Model / Serial
    Model Catalog: 60+00007791 (Lot serial: >10 numbers contact mfg)
  • Product Description
    IMPAX FOR CARDIOLOGY - CLINICAL REVIEW STATION
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

AGFA HEALTHCARE INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    HC