Events

Rappel de Artis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW version VC21B(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-2015-RN-00483-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-05
  • 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-2015-RN-00483-1
  • 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
    A possible position sensor fault in the swivel base axis not being detected by the system software may cause the c-arm system to move faster than normal when movement is enabled by the operator. the system will not move of its own accord, movement must still be initiated by the operator, however the system can unexpectedly exceed its usual speed, potentially resulting in a collision.
  • Action
    This issue will be remedied with software update (Patch 12). Following the installation of this update, the possible speed of the Artis system will be limited to the permissible level. This action has been closed-out on 19/08/2016.

Device

Artis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW ve...
  • Modèle / numéro de série
    Artis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW version VC21B(fluoroscopic angiographic x-ray system)Catalogue numbers: 10094135, 10094141, 10094139 ARTG Number - 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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