Events

Rappel de SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"

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-2015-RN-01057-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-29
  • 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-2015-RN-01057-1
  • 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 use of the combination phs1600 table with the perfusion scan mode 'adaptive 4d spiral' (typically used for critical diagnostic examinations) could occasionally initiate scan aborts. there is an increased risk of a scan abort when using the perfusion scan mode in combination with the phs1600 table, especially when applying contrast media. please note that the decreased performance stability is not affecting any other scan modes or the mechanical stability of the table in general.
  • Action
    Siemens is developing a solution for the use of the patient table PHS1600 in combination with the "Adaptive 40 Spiral" scan mode. Users are advised that they should be aware of the increased risk of a scan abort while using the perfusion scan mode in combination with the PHS1600 table. This action has been closed-out on 31/08/2016.

Device

SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D ...
  • Modèle / numéro de série
    SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"ARTG Number: 164065
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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