Events

Rappel de MONACO, version 5.10.00 and above (Radiation therapy 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-2015-RN-01023-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-10-20
  • 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-01023-1
  • 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
    1) in version 5.10.01, the isodose control 100% isodose value (second in the list) was linked to the dose normalisation (dn) value so users would always have a known normalisation value linked to 100% when in relative mode. when the 100% isodose value is edited on the isodose control, the dn is automatically updated. if the user does not notice this update & then rescales to a relative isoline & does not read the dn value displayed on the rescale bar, the rescale could be other than intended. 2) in version 5.10.00 or greater, when the user optimises, then changes the bolus assignment of the beams, and then selects “calculate” (not “optimize” again), the bolus assignment to beams can get scrambled. beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. the dose distribution and monitor units are incorrect. skin doses could either be higher of lower than intended and this increase or decrease in dose could exceed 5%.
  • Action
    1) The workaround is to only assign one value greater than 100% as the system is defaulted so the 100% isodose line and dose normalisation values are not affected. When rescaling, the dose normalisation value is displayed next to the re-scale value being entered by the user. 2) There is no workaround using the described workflow. However, the problem can be avoided by changing any bolus assignment before optimisation. Both problems will be resolved in Monaco Patch Release 5.10.02. This action has been closed-out on 22/08/2016.

Device

MONACO, version 5.10.00 and above (Radiation therapy treatment planning system)
  • Modèle / numéro de série
    MONACO, version 5.10.00 and above (Radiation therapy treatment planning system)ARTG number: 215960
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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