Events

Rappel de ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Brainlab Australia Pty 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-00218-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-08
  • 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-00218-1
  • 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
    After performing a snap verification, that is a monoscopic intra-fraction x-ray monitoring using only one x-ray tube, in combination with implanted markers, the exactrac 6.0 x-ray monitoring tab might display an incorrect hint icon and result text. exactrac might incorrectly show the hint icon in green colour with the result text “no deviation detected”, despite the simultaneously displayed unaffected x-ray image showing the actual positions of the implanted markers potentially deviating from the user defined tolerance areas .
  • Action
    Brainlab is asking customers to always verify the result of a Snap verification within the simultaneously displayed x-ray images generally required and never exclusively rely on the hint icon colour and the result text only. Brainlab will provide a software update to affected customers around end of August 2013 to correct the issue.

Device

ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)
  • Modèle / numéro de série
    ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System)ARTG: 121226
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd