Events

Rappel de Elekta Integrity R3.0 Digital Linear Accelerator

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-00375-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-30
  • 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-00375-1
  • 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 problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. a fault will occur is the loaded database is incorrect, and could cause clinical mistreatment.
  • Action
    Elekta is advising that the solution to this problem is to upgrade to IntegrityR3.1 as soon as it is available. An updater tool will be available within the next few months and will be Field Safety Modification number 200 02 502 030. This tool is a CD disk that Elekta Service will use on each product to check tolerances and it will adjust if necessary. This is a one-time check unless there is a change to the configuration, such as a new license for the LINAC and then a new check will be needed.

Device

Elekta Integrity R3.0 Digital Linear Accelerator
  • Modèle / numéro de série
    Elekta Integrity R3.0 Digital Linear AcceleratorARTG Number: 191025
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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