Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AGFA HealthCare Australia.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00317-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-04-18
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00317-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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