Events

Rappel de MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators

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-2013-RN-00585-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-06-06
  • 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-2013-RN-00585-1
  • 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
    It has come to the attention of siemens that one of their customers used film mode for image acquisition although it was not correctly calibrated, resulting in an overdose to several patients. film mode is a separate beam (dose set 8) and needs to be calibrated and verified prior to being used.
  • Action
    Siemens is providing additional calibration procedures and asking customers to make sure it is implemented. The physicist responsible for the system has to verify necessary system dosimetry for all beams used for patient treatment and imaging, in particular following a service intervention. Additionally, the necessary departmental QA procedures need to be followed. Siemens will also distribute information provided in the customer letter as an addendum to the user documentation.

Device

MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators
  • Modèle / numéro de série
    MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators ARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

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