Events

Rappel de MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators Multiple product codes

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens 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-2014-RN-01358-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-23
  • 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-2014-RN-01358-1
  • 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
    Siemens has received reports of one circuit board (g41) located inside of the linac gantry showing signs of overheating. after a detailed analysis the root cause was found to be one of the components that belong to this board (head driver pcb). siemens has redesigned the head driver pcb to further mitigate the risk of local overheating on the g41 motherboard.
  • Action
    Siemens has redesigned the Head Driver PCB to further mitigate the risk of local overheating on the G41 motherboard. The present corrective action comprises the replacement of the Head Driver PCB by a redesigned component on your LINAC. This action has been closed-out on 12/08/2016.

Device

MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators Multiple product codes
  • Modèle / numéro de série
    MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators Multiple product codesAll serial numbersARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA