Events

Rappel de Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning 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 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-2013-RN-00140-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-12
  • 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-2013-RN-00140-1
  • 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
    When an arc based plan is created, the beam will have a default "rotation_start" angle. if the start angle for the arc is edited and then the plan delivery type is changed to a non-arc beam, the rotation start angle does not update as it should. the result is that the beam is displayed at the 'gantry' angle, but the dose is calculated at the "rotation_start" angle. if the patient is treated at this beam gantry angle, the patient will not receive the dose that the treatment planning system has calculated and displayed.
  • Action
    The problem was introduced in Monaco Release 3.20.00. The issue is resolved in the Monaco 3.20.02 Patch Release and in Monaco Release 3.30.00. Elekta is asking customers to download software fix from its website.

Device

Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System)
  • Modèle / numéro de série
    Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System)ARTG Number: 186856
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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