Events

Rappel de Monaco V 5.00 and higher (Radiation therapy 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-2016-RN-01493-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-14
  • 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-01493-1
  • 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
    Contours are not handled correctly if the ct dataset contains slices with dicom z coordinates of xx.X50mm. if the ct data contain slices that occur at positions of xx.X50mm, there can be portions of the volume where there is a mismatch between the contour graphics shown on the screen and the contour data used during the optimisation and calculation of dose. unloading and reloading the patient data corrects the problem.Incorrect structure volumes can be used during optimisation. incorrect electron densities can be assigned to some regions of the patient.This can result in incorrect dose calculations. dose errors of greater than 5% can occur.
  • Action
    This problem will be resolved in Monaco release 5.30 and in patches to Monaco releases 5.10 and 5.11. In the interim, the problem can be avoided if the user takes the following action: - Following contour edits, perform an “Unload All” and reload the plan prior to performing dose calculation. This action has been closed-out on 26/05/2017.

Device

Monaco V 5.00 and higher (Radiation therapy treatment planning system software)
  • Modèle / numéro de série
    Monaco V 5.00 and higher (Radiation therapy treatment planning system software)ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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