Events

Rappel de Sensis 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-00521-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-24
  • 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-00521-1
  • 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
    In sensis systems, a computer that is extremely dusty can cause problems when starting the system. in rare cases, it can cause the sensis to fail. the system's functions cannot be used in the event of a failure and as a result, clinical treatment may need to be terminated, restarted, or transferred to a functioning system.
  • Action
    Siemens is currently working on a solution and will update users in the second quarter of 2017. In the interim, users are requested to conduct a system check to ensure that the system is functioning properly prior to performing an examination. In the event that the system fails to start within the time and parameters described in the operator manual, users are requested to notify Siemens Service, and terminate, restart or transfer clinical treatment to a functioning system. Users are to ensure that standard emergency processes are in place for implementation in the event of a system failure.

Device

Sensis system
  • Modèle / numéro de série
    Sensis systemCatalogue Numbers: 6634633, 6623974, 10764561 and 11007641ARTG Number: 273953
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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