Events

Rappel de ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par 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-2018-RN-00137-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-12
  • 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-2018-RN-00137-1
  • 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 exactrac on a varian clinac or varian truebeam system equipped with the adi, beam requests of the treatment application have to be authorized by exactrac to enable treatment. as per the ifu, if no patient data is loaded in exactrac, exactrac always authorizes every beam request from the varian side. this is required and intended for clinical treatments where exactrac is not used for patient positioning. brainlab is clarifiying that the beam authorization by exactrac via adi is not a safety feature to ensure correct patient positioning before treatment.For any treatments performed with exactrac always verify that exactrac confirms the target position by displaying the ok icon. if a deviation of the patient position from the planned treatment position remains undetected by the user and the actual treatment beam that has been previously authorized by exactrac via adi is initialized, underdose of the planned target and/or overdose of healthy tissue could occur.
  • Action
    Brainlab is advising users to always follow the IFU during use and to verify that ExacTrac confirms the target position by displaying the OK icon. Brainlab is providing updated Instructions for use. For treatments that have already been performed, the actual patient position during treatment can be reviewed in the treatment report of ExacTrac, and by using the Review function in the ExacTrac software.

Device

ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5
  • Modèle / numéro de série
    ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5ARTG Number: 121226 (Brainlab Australia Pty Ltd - ExacTrac / Novalis Body - Patient positioning device, diagnostic imaging/radiotherapy, whole body)
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd