Events

Rappel de Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based diagnostic imaging 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-00267-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-03-09
  • 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-00267-1
  • 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 issue can occur after the export of segmentation results of the left atrium created on syngo x workplace to an electro-anatomical 3d mapping carto system. after importing, the segmentation result appears mirrored at the carto system, and can't be used for the ablation procedure. although unlikely, there is a risk of serious health effects if the incorrect image is used for ablation.
  • Action
    Siemens is advising users that a software upgrade will be performed as a permanent correction. Users are advised to stop using any segmentation result for export to the CARTO system until the software upgrade is performed. This action has been closed-out on 25/01/2017.

Device

Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based...
  • Modèle / numéro de série
    Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based diagnostic imaging system)Catalogue Numbers: 10094165, 10281299 and 10502522 when used in combination with CARTO systemsARTG Number: 160940
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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