Events

Rappel de Monaco software versions 5.10.00 and higher

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-2016-RN-00651-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-05-25
  • 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-00651-1
  • 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 dicom is exporting a 3d monaco plan and the “composite field sequencing” (cfs) checkbox is selected, the y jaws will snap to the port shape when they should remain where they were defined. this occurs when the port shape used to define or edit the mlc positions extends beyond or inside the actual jaw positions. the defect is triggered when using a workflow for forward planning imrt that involves creating multiple beams for the same gantry angle with a single mlc shape defined for each beam. these beams are then exported using cfs to combine the individual 3d beams into a single imrt beam sequence. the planned and approved dose distribution will not agree with the dose delivered. this deviation is considered as a geometric miss and the patient can be overdosed or under dosed depending on whether the mlc shape is drawn outside or inside of the collimator jaws. there is a remote probability that serious injury could occur.
  • Action
    Elekta is advising users to avoid using the CFS option for any 3D delivery mode plan, including Forward IMRT based plans. A software correction will be implemented as a permanent correction. This action has been closed-out on 09/05/2017.

Device

Monaco software versions 5.10.00 and higher
  • Modèle / numéro de série
    Monaco software versions 5.10.00 and higherARTG Number: 215960
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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