Events

Rappel de SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM Force

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-01355-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-11-08
  • 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-01355-1
  • 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 risk of unnecessary radiation exposure due to a software issue in the care dose4d algorithm implemented in specific siemens ct scanners. this relates to possible incorrect tube current calculations by the care dose4d algorithm for head scans based on p.A. (posterior-anterior) or a.P. topograms. depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate. potentially, the care dose4d software will select the maximum tube current for the uppermost part of the skull, thus leading to unnecessary radiation exposure. the described issue will not occur when using a lateral topogram instead of a p.A. or an a.P. topogram. accordingly, siemens strongly recommends using topograms in lateral position for all head scans.
  • Action
    Siemens is advising users that the described issue will not occur when using a lateral topogram instead of a.p.a. or an a.p. topogram. Accordingly, Siemens strongly recommends using topograms in lateral position for all head scans. Siemens will be providing a software update as a permanent correction.

Device

SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM Force
  • Modèle / numéro de série
    SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM ForceCatalogue Numbers: 7740769, 8098027, 10590000, 10430603 and 10742326ARTG Number: 274034
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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