Events

Rappel de Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and specific manufacturing lots of 3 focal spot x-ray tube (fluoroscopic angiographic x-ray 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 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-01035-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-25
  • 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-01035-1
  • 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 identified a potential problem with the artis zee and artis zeego systems with the a100 generator and specific lots of a 3 focal spot x-ray tube. the “small focus” of a 3 focal spot x-ray tube may sporadically fail if the case grounding detaches from the focus head and overheating occurs. further radiation release won’t be possible. an ongoing procedure can be continued by using one of the two remaining focal spots ("large focus” or "micro focus") instead. to achieve that, the operator will need to switch over to the other focus, thus causing a short interruption of the ongoing procedure.
  • Action
    Siemens is implementing a software update that will protect the affected component from any damage in case the grounding detaches from the focus head. In case of such a potential failure, the system will automatically switch to the "Large Focus”. This action has been closed-out on 07/06/2016.

Device

Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and s...
  • Modèle / numéro de série
    Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and specific manufacturing lots of 3 focal spot x-ray tube (fluoroscopic angiographic x-ray system)ARTG number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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