Events

Rappel de Apex (Multileaf collimator used with Elekta linear accelerators)

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-00083-2
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-01-30
  • 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-00083-2
  • 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
    If the apex collimator has not been correctly installed on the radiation head and the user use the touchguard button to override the touchguard inhibit and rotate the gantry, the apex collimator can disconnect form the radiation head. this can occur because a fault condition that shows that the apex collimator was not attached correctly is bypassed.
  • Action
    Users are requested to include additional safety information provided with the customer letter in the instructions for use. The safety information requests users to ensure that they do not override the touchguard inhibit or rotate the gantry after installing the Apex collimator. The safety information also informs users that the View Restrictions dialogue box may not show the touchguard inhibit restriction if there are other restrictions present.

Device

Apex (Multileaf collimator used with Elekta linear accelerators)
  • Modèle / numéro de série
    Apex (Multileaf collimator used with Elekta linear accelerators)ARTG Number: 186855
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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