Events

Recall of IMPAX 5.2 DB Server, version 5.2 (Picture archiving and communication system, PACS)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AGFA HealthCare Australia.

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
    RC-2013-RN-00317-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-04-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00317-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 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.
  • Action
    Agfa HealthCare is advising that the ‘End of Service Life’ for IMPAX 5.2 was December 31, 2010. In order for Agfa HealthCare to continue to provide support, it is critical that sites upgrade to the latest version of IMPAX. In the interim, Agfa HealthCare strongly recommends installing the latest Oracle critical patch upgrades. Please see Oracle’s website for more details: http://www.oracle.com/technetwork/database/windows/downloads/index-101290.html .

Device

IMPAX 5.2 DB Server, version 5.2 (Picture archiving and communication system, PACS)

Manufacturer

AGFA HealthCare Australia