Events

Rappel de Wireless Foot Switch - Artis 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-2017-RN-00325-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-08
  • 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-00325-1
  • 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 whereby the gap in the housing of the wireless foot switch can result in liquids penetrating the interior. liquids may include disinfection and cleaning agents as well as bodily fluids. this can result in the failure of the foot switch. if the foot switch fails, it will no longer be possible to use it to release radiation. the hand switch provided can still be used to release exposures, but fluoroscopic examinations will not be possible. consequently, a situation may arise whereby it is necessary to cancel or restart clinical treatment or to transfer treatment to a functioning system.
  • Action
    Siemens is currently working on a solution which is expected during the second quarter of 2017. Siemens generally recommend the use of sterile covers to protect the foot switch from all types of contamination. This is an effective way to prevent the foot switch from coming into contact with liquids. In the event of foot switch failure, users are further advised that the release of radiation for imaging purposes is still possible using the hand switch. Users are to note that standard emergency processes should be in place and ready for implementation until corrective actions are carried out.

Device

Wireless Foot Switch - Artis systems
  • Modèle / numéro de série
    Wireless Foot Switch - Artis systemsCatalogue Numbers: 4787797, 4787805, 4787813(Artis Systems supplied after 01 January 2005)ARTG Number: 145549
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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