Events

Rappel de AlignRT patient positioning/tracking video camera system (when used withTrueBeam Radiotherapy Delivery System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par alphaXRT 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-00936-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-09-30
  • 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-00936-1
  • 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
    Vision rt has been notified that unintended changes can be made to the planned couch rotation parameter during patient set-up. this can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with the alignrt device prior to treatment with truebeam radiotherapy delivery system.When a request to update the couch position is sent to the truebeam via the alignrt device using the move couch function, the request may not be processed as expected. if the couch rotation in the alignrt device does not match the planned couch rotation of the field selected on the truebeam, this can result in a significant change to the planned couch rotation value. when the planned value is changed, the original plan value is overwritten at the console. this will result in the treatment plan couch value being updated unintentionally and a treatment misadministration may occur. there have been no reports of patient harm due to this issue.
  • Action
    Vision RT is advising users to not use the “Move Couch” function if the couch rotation value set in the AlignRT device does not match the planned couch rotation for the treatment field. Vision RT is investigating a solution for this issue.

Device

AlignRT patient positioning/tracking video camera system (when used withTrueBeam Radiotherapy Del...
  • Modèle / numéro de série
    AlignRT patient positioning/tracking video camera system (when used withTrueBeam Radiotherapy Delivery System)AlignRT PCR Number: 249-1526ARTG Number: 159239
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    alphaXRT Pty Ltd

Manufacturer

alphaXRT Pty Ltd