Events

Recall of IMPAX SERVER

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
    21933
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-19
  • 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
    System downtime and/or slow performance may result if software in use is not at supported levels. to be specific it has been identified that oracle version 10.1.0.4.0 or older in use with impax 5.2 db server can cause oracle blocking sessions due to defect 360595 with fix available in oracle 10.2.0.2. and subsequent versions. please see oracle's website detailing this defect and the associated fix: http://www.Oracle.Com/technetwork/database/windows/downloads/index-101290.Html.

Device

IMPAX SERVER
  • Model / Serial
    Model Catalog: IMPAX DB SERVER 5.2 (Lot serial: ALL)
  • Product Description
    IMAPX DB SERVER 5.2
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

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