Events

Rappel de Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4

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

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-2016-RN-00637-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-05-13
  • 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-2016-RN-00637-1
  • 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
    On the affected ct systems and software versions, varian rpm drive is not mapped in ct user profile after logout/login. the map drive utility maps the varian drive using full varian credentials in the service login and then creates a script that maps it with full varian credentials in the ct user login. once the script has run in the ct login and the user acknowledges the drive mapped successfully, the script deletes itself. on subsequent logins, the drive will not connect because the varian credentials are no longer available. should this situation occur, the user will be unable to perform pulmonary gated scans.
  • Action
    Philips is advising users to contact Service to login to service mode to reconnect Varian RPM drive. Philips is implementing a software upgrade as a permanent correction. This action has been closed out on 15 June 2017.

Device

Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4
  • Modèle / numéro de série
    Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA