Events

Rappel de Biograph, Symbia T and Symbia Intevo SPECT/CT systems

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-2018-RN-00654-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-05
  • 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-2018-RN-00654-1
  • 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 healthineers are aware of potentially incorrect tube-current calculations by the care dose4d algorithm when utilising only pa or ap topograms. depending on the geometrical shape of the skull, rare cases may occur in which the calculated dose distribution is not appropriate for scans that include the head, when based only on pa or ap topograms. the care dose4d software may select the maximum tube current for the uppermost part of the skull, which incidentally leads to unnecessary radiation exposure.
  • Action
    Siemens is advising that the manufacturer is developing appropriate solutions to address the problem with high priority. The described issue does not occur when using a lateral topogram. Accordingly, Siemens strongly recommend the utilization of topograms in the lateral position for all CT and PET/CT scans that include the entire head. Alternatively, if users choose to perform both a lateral topogram, in conjunction with a PA or AP topogram they must ensure that they perform the lateral topogram last as CARE Dose4D is based on the last topogram. If users do not utilize a lateral topogram for scans including the entire head, Siemens strongly recommend that users deactivate the CARE Dose4D feature.

Device

Biograph, Symbia T and Symbia Intevo SPECT/CT systems
  • Modèle / numéro de série
    Biograph, Symbia T and Symbia Intevo SPECT/CT systemsCatalogue Numbers: 8728581, 10097303, 10097289, 10097302, 10532746, 10532748, 10528958, 10529158, 10529160, 10529161, 10528955, 10507786, 10507786, 10534160, 10248669, 10248672, 10248673, 10248670, 10525581, 10764804, 10764802, 10764803, 11007962, 10764801, 10275007, 10275010, 10275008, 10275009 and 8717733.ARTG Numbers: 123883, 144218 and 271560.
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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