Events

Rappel de SOMATOM CT System SOMATOM Definition Flash running software version syngo CT2012B SOMATOM Definition Edge running software version syngo CT2012B SOMATOM Definition AS running software version syngo CT2012B SOMATOM Definition running software version syngo CT2012B SOMATOM Definition AS running software version syngo CT2013

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-2013-RN-01317-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-11
  • 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-2013-RN-01317-1
  • 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 software malfunction that may lead to a system display freeze during interventional procedures. if the function, "auto save last displayed images as key images" is activated during an interventional procedure, the software configuration allows conflicting access to the ct system image database. in such situations, a system display freeze might occur. normal interaction with the system is then no longer possible. no error message is issued and only a system restart resolves the problem. in case of a sudden system display freeze the interventionalist will potentially not immediately recognise the malfunction and continue the interventional procedure. there is a possibility of injury to a patient.
  • Action
    Siemens advising users to deactivate the "Auto save last displayed images as key images" function to prevent the issue from occurring. Images can continue to be saved manually. Siemens is providing a software update to permanently correct the issue in February 2014. This action has been closed-out on 29/01/2016.

Device

SOMATOM CT System SOMATOM Definition Flash running software version syngo CT2012B SOMATOM Definit...
  • Modèle / numéro de série
    SOMATOM CT System SOMATOM Definition Flash running software version syngo CT2012BSOMATOM Definition Edge running software version syngo CT2012BSOMATOM Definition AS running software version syngo CT2012BSOMATOM Definition running software version syngo CT2012BSOMATOM Definition AS running software version syngo CT2013BARTG numbers: 164065 (SOMATOM system),160853 (syngo software)
  • Manufacturer
    Siemens Ltd

Manufacturer

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