Events

Rappel de MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record)

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-2017-RN-00836-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-04
  • 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-2017-RN-00836-1
  • 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
    The machine characterization (mac) file is instrumental to the correct operation of mosaiq and your elekta linac. elekta has become aware of the potential for incorrect characterization of couch values, which will lead to incorrect table movements when using couch move assistant (cma). if the mac file is set up incorrectly it is possible that table shifts can be made in the wrong direction.
  • Action
    Elekta is requesting the following: 1. If you are using the Couch Move Assistant (CMA) feature in MOSAIQ , run the verification test(s) given in the Customer Letter to ensure that your table is operating correctly; 2. Users should only run the tests applicable to your clinical workflows on all of your Elekta linacs that are configured for CMA; 3. If the test(s) pass successfully, sign the Acknowledgement form and return the form to Elekta; and 4. If the test(s) fail contact your local Elekta Care Support Centre for assistance.

Device

MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information sys...
  • Modèle / numéro de série
    MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record)Elekta Reference Number: FCA-IMS-0024ARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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