Events

Rappel de AlignRT patient positioning/tracking video camera system Software versions up to, but not including, 5.0.1691 Affected hardware configuration: Vision RT external Gate Controller with Varian Motion Management Interface (MMI) or Siemens systems. Systems with Vision RT’s Integrated Gate Controller (IGC) are not affected.

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-2014-RN-01220-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-14
  • 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-01220-1
  • 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
    Contrary to the recommended start-up sequence, if the user starts the vision rt software with the gate controller key-switch in the off (‘0’) position and then turns the gate controller key-switch from the off (‘0’) to the on (‘1’) position, a message informing that the current key-switch position is ‘0’ is displayed to the user. if the user was to continue, the real time deltas displayed on the main screen of the device would correctly indicate the actual position of the patient with respect to the user-configured thresholds, but the software is not gating. if users ignore the warnings, when the patient moves out of position and the software requests a beam hold, the request is ignored by the gate controller and beam will continue to be enabled. if users fail to recognise that real time deltas are out of tolerance and the linac control console is providing visual and audible indication that the beam is on, this may lead to a geographic treatment target miss for part of the dose.
  • Action
    Users are advised that the device remains safe to use if the instructions detailed in the customer letter and in the Product Guide are followed. In addition, Vision RT is in the process of designing an upgrade in order to prevent this potential issue. Vision RT will contact customers by 31 March 2015 in order to update them on the status of this upgrade and to plan its installation.

Device

AlignRT patient positioning/tracking video camera system Software versions up to, but not includi...
  • Modèle / numéro de série
    AlignRT patient positioning/tracking video camera system Software versions up to, but not including, 5.0.1691Affected hardware configuration: Vision RT external Gate Controller with Varian Motion Management Interface (MMI) or Siemens systems. Systems with Vision RT’s Integrated Gate Controller (IGC) are not affected.Serial Numbers: 247-034 & 247-035ARTG Number: 159239
  • Manufacturer
    alphaXRT Pty Ltd

Manufacturer

alphaXRT Pty Ltd