Events

Rappel de Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030

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-01196-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-12
  • 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-01196-2
  • 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
    While performing high resolution head scans, the reconstructed images may exhibit degraded image quality manifested as:- non uniformity of the image, - ct number shift, greater than 5 hounsfield units,- reduction in grey/white matter differentiation. the issue is most severe in the high resolution mode. philips provides factory reference paediatric scan protocols which are set to high resolution by default. adult head scans have a factory reference protocol that defaults to standard resolution which does not experience the issue.
  • Action
    Philips is advising users to perform head scan with standard resolution across all patient populations on systems running the affected software. Philips will be implementing a software correction as a permanent correction. This action has been closed-out on 15/03/2018.

Device

Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030
  • Modèle / numéro de série
    Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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