Events

Rappel de iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Software)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Brainlab Australia 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-2015-RN-00616-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-07-08
  • 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-2015-RN-00616-1
  • 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
    The automatic monitor units (mu) calculation (normalisation) might be incorrect in the brainlab iplan rt dose versions 4.0 and 4.1 if all of the following conditions are met: - several ptvs are planned in the treatment plan, and - at least one treatment group or treatment element is locked to prevent further modification, and - for any ptv with a locked treatment group or with at least one locked treatment element assigned the dose at the 50% volume constraint point deviates more than 5% from the actual dose at 50% volume.If the mu calculation is refreshed, the software will always normalise the dose of the ptvs, which do not have a locked treatment group or treatment element assigned, to the 50% volume constraint point. other constraint points for the ptvs will be disregarded even if a constraint point is set “hard constraint” and therefore the intended prescription will not be automatically fulfilled for ptvs without a locked treatment group or locked treatment element.
  • Action
    Brainlab will provide a software solution to prevent the described scenario from occurring. Brainlab will actively contact affected customers starting January 2016 to schedule the update. This action has been closed-out on 12/08/2016.

Device

iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Soft...
  • Modèle / numéro de série
    iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Software)ARTG Number: 121114
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd