Events

Rappel de Brilliance iCT and iCT SP up to and including Software Version 3.2.5

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-2013-RN-00766-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-07-24
  • 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-00766-1
  • 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
    When using 80kvp with intravenous contrast in head and neck studies with u-filters (ua, ub, uc), a vascular artefact that resembles thrombus may appear on the image. there is a risk of misdiagnosis which can lead to unnecessary treatment of a patient. for certain patient populations, this could contribute to serious injury.
  • Action
    When the settings (80 kVp with intravenous contrast in head and neck studies with U-filters (UA, UA and UC)) are used, Philips recommends performing additional reconstruction with a non-U filter and comparing the result images to verify no such artefact is evident. Customers are advised to continue to use 80 kVp with U-filters for brain perfusion scans. Refer to the Instructions for Use (IFU) for the selection of an arterial input unaffected by discontinuity should one occur.

Device

Brilliance iCT and iCT SP up to and including Software Version 3.2.5

Manufacturer

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