Events

Rappel de Artis Q Systems with A100G generators

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 Healthcare 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-00303-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-02
  • 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-00303-1
  • 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
    In artis systems with a100g generators, a component can be affected by ageing, resulting in the failure of a module in the high-voltage generator. when the failure occurs, the system usually responds by providing emergency fluoroscopy. in the worst case, a spontaneous failure of the radiation generation function is conceivable. in the event of a spontaneous failure, it may be necessary to cancel or restart a clinical treatment or transfer it to a functioning system.
  • Action
    Siemens is advising users that potentially affected modules will be replaced. Users are further advised to implement standard emergency processes in the event of a system failure and to have these processes carefully prepared until the affected modules are replaced.

Device

Artis Q Systems with A100G generators
  • Modèle / numéro de série
    Artis Q Systems with A100G generators Catalogue Numbers: 10848353, 10848354, 10848355, 10848280, 10848281, 10848282, 10848283ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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