Events

Rappel de Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air), software version 3.6.0

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-00941-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-06
  • 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-00941-1
  • 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
    There are artifacts appearing on the tracker images during threshold-triggered bolus scans with protocols using a rotation time of 0.4 seconds. in those cases only, the scan might be triggered either too soon or too late, which may lead to inappropriate contrast opacification during the clinical scan. if the acquired images are not diagnostically acceptable, a rescan of the patient need to be performed.
  • Action
    Clinical judgment should be used by the customer/user to determine if the images acquired in the dataset contain enough information to make a diagnosis. Philips Healthcare is implementing software update version 3.6.2 to correct the issues.

Device

Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air), sof...
  • Modèle / numéro de série
    Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air), software version 3.6.0 ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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