Events

Rappel de SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray 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-01461-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-09
  • 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-01461-1
  • 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
    Customers with software version va50_sp2 will be provided an update to software version va50_sp3. the installation of this update will address software bugs that were identified through field monitoring. some of the major bug fixes that will be addressed with this software are:1) correction to volumetric misrepresentations of high contrast objects when using admire.2) correction to highly sporadic scan aborts due to temporarily tube currents at 0ma.3) correction to missing microsoft hotfixes (ms16-001, ms15-135, ms15-088, ms15-048). 4) correction to highly sporadic image artefacts caused by error signals from high voltage chain at extremely high tube currents.5) correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed.6) correction to highly sporadic scan aborts due to temporarily high disk load of system disk.7) correction to highly sporadic image artefacts generated by scatter correction in case of tube arcing.
  • Action
    Customers are advised that the update will be remotely pushed to the system or Siemens will contact customers to arrange a date for the installation of the software update onsite.

Device

SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)
  • Modèle / numéro de série
    SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)ARTG Number : 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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