Events

Rappel de HexaPOD evo RT System with HexaPOD evo Module

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-2018-RN-00560-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-05-22
  • 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-2018-RN-00560-1
  • 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
    Upon completion of a 6d workflow, the hexapod evo module may be in a tilted state, if it is moved to the position used for 3d (non-iguide) treatments. in a subsequent 3d workflow, a possible incorrect position of the patient, due to a tilt of the hexapod, may be difficult to detect without verification. this description is not relevant for an iguide workflow (6d). the problem occurs only when a user switches from a 6d to a 3d workflow without iguide.
  • Action
    Elekta is advising customers the correct position will be reached when the command to move the HexaPOD to the predefined 3D position is repeated. Users must perform this additional step without a patient on the HexaPOD after each change from the 6D workflow to the 3D workflow. Please refer to the respective User Manual for details how to initiate the movement. The manufacturer is currently investigating solutions to rectify this issue. Once available, Elekta will contact users to coordinate the required actions.

Device

HexaPOD evo RT System with HexaPOD evo Module
  • Modèle / numéro de série
    HexaPOD evo RT System with HexaPOD evo ModuleARTG Number:187340(Elekta Pty Ltd - Table, radiation therapy, x-ray, powered)
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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