Events

Rappel de Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumours and other conditions requiring radiation therapy)

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-2012-RN-00852-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-08-21
  • 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-2012-RN-00852-3
  • 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
    Varian is notifying customers of an anomaly identified with the clinac, trilogy, novalis tx and unique jaw carriers. some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an under-dose of the intended target volume.
  • Action
    Onsite inspection and replacement of jaw carriers. This action has been closed-out on 18/02/2016.

Device

Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radi...
  • Modèle / numéro de série
    Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumours and other conditions requiring radiation therapy)Product codes: H14, H18, H29Affected Serial Numbers: H140865, H140898, H140899 and H294667ARTG Number: 116839
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd