Events

Rappel de SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic 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-2016-RN-01433-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-03
  • 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-2016-RN-01433-1
  • 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
    The small light marker window used for the positioning laser and integrated in the front cover of the ct that had loosened in the past and had been subsequently fixed, could now become loose again and potentially drop out. in this case, there is a risk that a person could touch rotating or electrical parts of the gantry when reaching through the window opening. there is a risk for serious injury e.G. by electrical shock or physical harm to fingers.
  • Action
    Siemens is developing a solution for the problem and this will be implemented as a permanent correction. In the interim, users should maintain awareness until a solution is implemented. They should not use the CT system in case a light marker window is missing or loose and is advised to inform the Siemens Service immediately.

Device

SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)
  • Modèle / numéro de série
    SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)Catalogue Numbers: 8098027, 10430603ARTG Number: 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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