Events

Rappel de Monaco 5.10.00(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-00910-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-09-16
  • 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-2015-RN-00910-1
  • 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)dose and mu incorrect when ct images viewed from the head: ct images are typically presented as if the viewer is standing at the foot of the couch and looking toward the patient’s head. however, for neurosurgery, images are often created as if being viewed from the top of the couch looking toward the patient’s feet. when ct images are created this latter way and imported in monaco, the image is displayed correctly but the electron densities are incorrectly flipped in both the right-left and superior-inferior directions. the dose distribution and monitor units will be incorrect. 2)dose and mu incorrect when using multiple prescriptions with forced densities:when using multiple prescriptions and the first prescription has forced densities, these forced densities are not being maintained with the second prescription. the dose distribution and monitor units will be incorrect as the initial prescription will use forced densities and the second prescription will use ct densities.
  • Action
    Elekta is advising customers that both problems will be resolved in Monaco Patch Release 5.10.01 which will be available for general release in late September. This action has been closed-out on 19/08/2016.

Device

Monaco 5.10.00(Radiation therapy treatment planning system)
  • Modèle / numéro de série
    Monaco 5.10.00(Radiation therapy treatment planning system)ARTG: 215960
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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