Events

Rappel de Digital Accelerators with iViewGT or XVI

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-2017-RN-01480-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-12-04
  • 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-2017-RN-01480-1
  • 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
    Elekta has identified that if the microswitch in the pcb assembly, solenoid limit switch of the middle arm is not set up correctly, it is possible to get an uncontrolled extension of mv or kv detector arms. it is possible that a collision with the extended arm can cause serious injury. when the detector arm is fully extended there is no risk.
  • Action
    Recommended User Action: Elekta recommends that the user does not open or close the detector arm when it is positioned above the patient, as specified in the Instructions for use (IFU). iViewGT Elekta recommends that the detector panel is not opened or closed when the gantry is at 180° (±45°), especially when a patient is on the treatment table. The movement of the MV detector panel at these angles can disturb a patient if they are below the detector panel. XVI Elekta recommends that you do not open or close the detector arms when they are in a position above the patient. Distribute the supplied notice to all users of the system at your facility. Include a copy of the supplied notice with the system manuals. To acknowledge the receipt of this letter please complete the Confirmation of receipt form you receive from Elekta's automated distribution system. Return the form even if you no longer have the affected units at your site.

Device

Digital Accelerators with iViewGT or XVI
  • Modèle / numéro de série
    Digital Accelerators with iViewGT or XVI ARTG number: 111760
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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