Events

Rappel de Clinac, Trilogy, Trilogy Tx, Novalis Tx and Unique accelerators, software versions 7.x, 8.x and 9.0. (Linear accelerator 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 Varian Medical Systems Australasia 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-01133-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-06
  • 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-01133-1
  • 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
    The manufacturer has received reports in which a user has remotely rotated the gantry into contact with the couch or with patients, in both the manual mode and the automated mode.
  • Action
    Varian is reminding users to ensure patients are observed during manual and automatic gantry movements. Varian is providing a software update to permanently correct the issue. This action has been closed-out on 01/02/2016.

Device

Clinac, Trilogy, Trilogy Tx, Novalis Tx and Unique accelerators, software versions 7.x, 8.x and 9...
  • Modèle / numéro de série
    Clinac, Trilogy, Trilogy Tx, Novalis Tx and Unique accelerators, software versions 7.x, 8.x and 9.0. (Linear accelerator system)Product Codes: H14, H18, H27 and H29ARTG Number: 116839
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd