Events

Rappel de Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of head structures)

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-2016-RN-00410-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-04-06
  • 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-2016-RN-00410-1
  • 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
    There is a potential for incorrect mounting of the frame adapter to the coordinate frame. the latches of the frame adapter can be locked even if the locating pins of the frame adapter are not inserted into the corresponding holes in the coordinate frame. if the frame adapter is mounted incorrectly to the coordinate frame and this is not noticed by the user before treatment is started, dose will be delivered in the wrong place by up to 2cm.
  • Action
    Elekta is advising users that the frame adapter is safe to use provided that the Instructions for use are followed and conducted by a trained professional. It is of the highest importance that the frame adapter is mounted to the coordinate frame as described in the applicable Instruction for Use. The locating pins of the frame adapter shall be inserted into the corresponding holes in the coordinate frame before the three latches are locked. Also make sure that only trained personnel are involved in mounting the frame adapter. A field corrective action will be implemented to facilitate a correct mounting of the frame adapter.

Device

Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of he...
  • Modèle / numéro de série
    Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of head structures)ARTG Number: 182102
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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