Events

Rappel de Artis One in conjunction with table

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-00054-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-19
  • 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-00054-1
  • 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 been made aware of an issue with the artis one systems in conjunction with artis tables. the artis table top carriage is mounted on top of the table base and fixed with a bolt. a fixation ring is used to secure the bolt. in the event of a missing or wrongly installed fixation ring, the bolt will remain in place and the patient table may appear to operate normally. in extreme cases after long periods of use, the bolt persistently bears the unexpected force from non-vertical direction and may slide out of its base and lead to the table top carriage slide to the floor. no complaints have been received for the artis one system to date.
  • Action
    Siemens will be in contact with affected users to arrange for a service technician to examine potentially affected tables. The positioning of the bolt as well as the fixation rings will be verified and if necessary corrected or replaced.

Device

Artis One in conjunction with table
  • Modèle / numéro de série
    Artis One in conjunction with tableCatalogue number – 10848600ARTG number – 222194 (Siemens Healthcare Pty Ltd- Artis one - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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