Events

Rappel de Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) 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-00401-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-04-05
  • 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-2016-RN-00401-1
  • 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 manufacturer has advised that the use of the neonate head protocol with the paediatric kernel hp38 could result in artefacts and possibly lead to misdiagnosis. either not existing blood or liquid is mimicked in the images or actually existing blood or liquid is not depicted as expected. investigations revealed a wrong parameterisation of the reconstruction algorithm applied for the paediatric head kernel as cause of the problem. this does not affect other kernels or reconstruction modes.
  • Action
    Siemens is advising users not to use the Neonate Head protocol with paediatric kernel Hp38 and is recommending using kernel Hr38 instead. The reconstruction of images is based on raw data, the data acquisition parameters are not affected and no additional dose is applied to the patient. A software upgrade will be performed as a permanent correction. This action has been closed-out on 03/02/2017.

Device

Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed T...
  • Modèle / numéro de série
    Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system)Catalogue Number: 10742326 ARTG Number: 164065
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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