Events

Rappel de Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 and 10

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-00920-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-09-07
  • 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-00920-1
  • 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 the clock on the eclipse client workstation is running behind the clock on the database/system server, it is possible that a change to the assigned hu value for a structure dose not invalidate the density image stored in the cache, and for the subsequent dose and monitor unit calculation to be based on the outdated hu assignment. the resultants mus may be higher or lower than expected. treatment of the patient using these values can lead to under or overdosing.
  • Action
    Varian is providing users with work around instructions and will be providing a technical correction to permanently correct the issue when available.

Device

Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 a...
  • Modèle / numéro de série
    Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 and 10Product Code: H48Multiple serial numbers affectedARTG Number: 119983
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd