Events

Rappel de Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive 3D Intervention option

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-2014-RN-01243-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-11-21
  • 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-2014-RN-01243-1
  • 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 a potential malfunction that may cause a display freeze during ct interventional procedures. the user interface may lock-up when performing an adaptive 3d interventional procedure when the "auto save at last displayed images as key images" is enabled. when the issue occurs, normal interaction with the system is no longer possible and no error messages are displayed. therefore the end-user and/or interventionalist may not know that the system has stopped interacting and continue wiht the interventional procedure.
  • Action
    Siemens is advising their customers to reconfigure the system Storage to deactivate "Auto save at last displayed images as key images". A software update will be implemented to correct the problem. This action has been closed-out on 18/03/2016.

Device

Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive ...
  • Modèle / numéro de série
    Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive 3D Intervention optionSoftware version: VG50AARTG number: 144218
  • Manufacturer
    Siemens Ltd

Manufacturer

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