Events

Recall of ENTERPRISE IMAGING DESKTOPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGFA HEALTHCARE N.V..

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
    30344
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-27
  • 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
    Additional addendums sent from enterprise imaging to an external ris/his is sent with the same date/time-stamp in obr-22 (results rpt/status chng - date/time) as the one from the first addendum. this may lead to addendum workflow issues. this issue may lead to the addendum not being stored in the ris/his system and the addendum information not being considered by referring physicians/clinicians when making medical decisions.

Device

ENTERPRISE IMAGING DESKTOPS
  • Model / Serial
    Model Catalog: 8.1.1 (Lot serial: N/A); Model Catalog: 8.1 (Lot serial: N/A); Model Catalog: 8.0.1 (Lot serial: N/A); Model Catalog: 8.0.0 (Lot serial: N/A)
  • Product Description
    Enterprise Imaging
  • Manufacturer
    AGFA HEALTHCARE N.V.

Manufacturer

AGFA HEALTHCARE N.V.
  • Manufacturer Address
    MORTSEL
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    HC