Events

Rappel de Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation therapy treatment)

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-2013-RN-00532-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-06-03
  • 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-2013-RN-00532-1
  • 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
    After the mandatory upgrade of xvi systems from xvi r4.5 to r4.5.1 (tga reference: rc-2012-rn-00456-3), elekta has found that some customers are still operating on the incorrect software build of the xvi r4.5.1 b138 software. the correct build is r4.5.1 b141. the software update from r4.5 to r4.5.1 (tga reference: rc-2012-rn-00456-3) was to permanently correct a software problem that prevents the operation of the database reindex function and also, prevents the error that incorrectly causes a kv gating inhibit during segmental volumeview.
  • Action
    If XVI Release 4.5.1 b141 is displayed on the logon screen, no further action is required. If XVI Release 4.5.1 b138 is displayed end users must contact their service representative immediately. Instructions to complete the upgrade to the correct software build are also being provided to end users.

Device

Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation thera...
  • Modèle / numéro de série
    Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation therapy treatment)Software version 4.5.1 b138ARTG number: 165040
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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