Events

Rappel de ARTIS pheno systems

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-2018-RN-00471-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-18
  • 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-2018-RN-00471-1
  • 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 an issue with artis pheno systems. if the c-arm is moved manually longitudinal to a fully extended position it may occur rarely, that the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the movement and can drop up to 20 mm (0.8"). this can happen during an ongoing procedure.If this issue occurs, the system performs a safety stop. all c-arm movements are blocked and can only be reactivated by a field service engineer.
  • Action
    Siemens are currently working on a solution to eliminate the root cause of the problem. In the interim, users are advised to avoid driving the C-arm into a fully extended longitudinal position. A fully extended longitudinal position is reached when the stand arms are almost completely stretched out.

Device

ARTIS pheno systems
  • Modèle / numéro de série
    ARTIS pheno systemsCatalogue Number: 10849000ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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