Events

Rappel de Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic digital 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 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-00228-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-14
  • 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-00228-1
  • 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 the current operating instructions. an existing system function is not fully described in the operating instructions, and this function may allow users to complete a treatment or diagnosis despite a defective focus.For artis systems with the specified software versions, a semi-automatic focus switch is implemented. interacting with a special type of defect due to wear in the foci "small" and "micro" (if present), this performs an automatic focus switch when the footswitch is pressed several times. this special system function is not fully described in the operating instructions currently available. if a focus (small/micro) develops a defect, an alternative focus can be selected by pressing the footswitch several times. this enables radiation to be generated once again so that the clinical treatment or diagnosis can be continued.
  • Action
    Siemens is providing supplement to the operating instructions that describes the corresponding "system messages" for the existing system function and explains how to use the function properly in the event of a fault. This action has been closed-out on 01/03/2018.

Device

Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic di...
  • Modèle / numéro de série
    Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic digital x-ray system)Catalogue Numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848355 ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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