Events

Rappel de XiO Software build versions 4.1 and higher (Radiation therapy treatment planning 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 Elekta 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-2014-RN-00275-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-03
  • 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-2014-RN-00275-1
  • 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
    Dose and monitor unit values are not computed correctly when elekta motorised wedges are used with dynamic conformal arcs. the problem occurs because only the start and stop angles of the dynamic conformal arcs are computed when all sub-beams of the arc should be computed. the planned dose distribution will not reflect the delivered dose. some anatomical structures will receive more dose than the plan reflects, some will receive less dose. it is possible that the target could likewise receive more or less dose than what is reflected in the plan. there is a remote probability of a mistreatment resulting in serious injury.
  • Action
    Users are advised that the problem can be avoided by not using Elekta Motorised Wedges with Dynamic Conformal arcs. The problem was introduced in XiO Release 4.1 and will be resolved in Release 5.00.01 which will be released by March/April 2014.

Device

XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)
  • Modèle / numéro de série
    XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)ARTG Number: 99769
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    DHTGA