Events

Rappel de SOMATOM Force with software version VA50A

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-00487-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-19
  • 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-00487-1
  • 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
    An addendum is to be added to the instructions for use (ifu) of the somatom force system with software version va50a which is related to the use of the turbo flash mode with very short scan ranges. when selecting the turbo flash mode in combination with a spiral scan length of less than 27 mm the image reconstruction will possibly fail for this scan. as a workaround the addendum states for the turbo flash mode to always select a spiral scan length higher than 27 mm or to switch to another mode instead.
  • Action
    Siemens is advising users to always select a spiral scan length higher than 27mm or to switch to another mode when selecting the Turbo Flash Mode in combination with a spiral scan length of less than 27mm. (This information is contained in the addendum which will be posted to users). Users are requested to place this addendum in their User Manual and to disseminate the information to the relevant personnel at their organisation.

Device

SOMATOM Force with software version VA50A
  • Modèle / numéro de série
    SOMATOM Force with software version VA50ACatalogue Number: 10742326ARTG Number: 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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