Events

Rappel de Monaco RTP System (Radiation Treatment Planning System 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 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-00708-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-07-16
  • 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-00708-1
  • 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
    This issue affects monaco releases that have been upgraded to 3.20.00 (from 3.10.00) and 3.30.00 (from 3.20.00) and a sample couch parameter file has been edited and saved prior to the upgrade. if the sample couch parameter files are edited (post upgrade), the densities altered, and "save" is selected, the sample files will be updated with these new, user defined densities. if these changes are saved under the original name, when a software upgrade is loaded, the modified couch densities in these sample files will be overwritten with the default value of 1.000.
  • Action
    Elekta is providing work around instructions for users to follow as an interim measure, Elekta is currently working on a preventative action, and will provide further information once this has been determined.

Device

Monaco RTP System (Radiation Treatment Planning System Software)
  • Modèle / numéro de série
    Monaco RTP System (Radiation Treatment Planning System Software) Release 3.20.00 and 3.30.00 upgraded from 3.10.00 or 3.20.00 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