Events

Rappel de HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)

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-00468-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-23
  • 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-00468-1
  • 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
    If the screws that secure the hexapod evo rt couchtop are not adequately tightened during installation, they may loosen over time. this condition has the following possible impacts: - there may be incorrect patient repositioning if the hexapod evo rt couchtop is moved.- the hexapod evo rt couchtop could tip when a patient is in a highly extended position (which could be the case in treatments of the lower body half).
  • Action
    Elekta is advising their customers to check each screw to determine if it is loose. If any screw is loose the HexPOD evo RT system must be taken out of service and the service engineer responsible for the equipment should be contacted. The service engineer will tighten the screws to 20 Nm before the couchtop can be used.

Device

HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)
  • Modèle / numéro de série
    HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)ARTG Number: 187340
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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