Events

Rappel de Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use)

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-00255-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-22
  • 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-00255-1
  • 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 column rotation can accidentally be moved to a different position while in the locked position. this can occur between fields and can cause clinical mistreatment.
  • Action
    Elekta has provided work around instructions to ensure the treatment table is in the correct position. If end users determine that it is possible to rotate the column with the brakes applied they must contact their service representative. Elekta is currently developing a correction to repair the problem.

Device

Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning ...
  • Modèle / numéro de série
    Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use)Ranges: 124001 to 126924, 133801 to 133999, 213000 to 213189ARTG Number: 165045
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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