Events

Recall of IMPAX CARDIOVASCULAR

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
    31408
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-21
  • 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
    When more than one instance of outbound is running (either outbound.Bat or outbound as a windows service) report mis-attribution can occur. the symptom is: for one study patient information shows correctly on the preliminary report but shows a different patient on the final report. this situation occurs if a system is accessed via non-console rdp connections. batches or scripts placed in the startup folder (including outbound) of the corresponding domain user account are launched which can result in multiple sessions of outbound running at the same time. multiple sessions of outbound running concurrently introduces the potential for data mis-attribution.

Device

IMPAX CARDIOVASCULAR
  • Model / Serial
    Model Catalog: 7.X (Lot serial: CV 7.4); Model Catalog: 7.X (Lot serial: CV 7.8)
  • Product Description
    IMPAX CV REPORTING
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

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