Events

Rappel de Desktop Pro R7.01 SP2 and Desktop Pro R4.2, R5.0, R5.1, R6.0, R6.1 (Linear accelerator 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-00019-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-01-13
  • 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-00019-1
  • 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
    During the treatment table, gantry and collimator calibration procedures, it is possible to type the incorrect values or invert a value. if the user does not do the quality assurance (qa) procedures after the calibration, it is possible that the user will not find the error made during the calibration. this could result in delivering the treatment with the patient in the incorrect position resulting in clinical mistreatment.
  • Action
    Users are asked to undertake QA procedures in accordance with the instructions for use (IFU) for Integrity, Precise Table and X-ray Volume Imager (XVI). Users will be informed of the mandatory software upgrade upon its release (expected early 2014) which will mitigate the issue. This action has been closed-out on 02/02/2016.

Device

Desktop Pro R7.01 SP2 and Desktop Pro R4.2, R5.0, R5.1, R6.0, R6.1 (Linear accelerator system)
  • Modèle / numéro de série
    Desktop Pro R7.01 SP2 and Desktop Pro R4.2, R5.0, R5.1, R6.0, R6.1 (Linear accelerator system)ARTG Number: 111760
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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