Events

Recall of IMPAX

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
    28997
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-25
  • 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
    Unexpected behavior can occur when the user selects patient studies for display. a relevant prior study can unexpectedly display instead of the study selected. if a prior study must be retrieved (because "relevance" is selected and the prior study is not readily available locally) and the retrieval of the prior study completes before the selected study is available for display then the prior study will display instead of the selected (current) study.

Device

IMPAX
  • Model / Serial
    Model Catalog: 6.6 (Lot serial: software version 6.6.1); Model Catalog: 6.5 (Lot serial: software version 6.6.1); Model Catalog: 6.6 (Lot serial: software version 6.5.5); Model Catalog: 6.5 (Lot serial: software version 6.5.5)
  • Product Description
    IMPAX PACS
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

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