Events

Rappel de syngo X-Workplace with software VD10E and tabcard ”4D”Siemens

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-01151-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-01
  • 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-01151-1
  • 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
    There is a software related issue with the syngo x-workplace (s/w vd10e) and tabcard "4d" viewer application. when a volume is acquired with a ct scanner with a tilted gantry, the measurements displayed in the 4d tabcard can be incorrect, due to incorrect calculations in the multi-planar reformattings (mprs) of the volume. this might potentially result in the physician selecting a device with the wrong size (too small), which then needs to be exchanged. in the event that the device needs to be exchanged, it could lead to a medium term delay in a clinical procedure.
  • Action
    The sponsor Siemens will contact the affected customers to arrange for the installation of a software update which will eliminate the reported problem. Users are advised to load the MPR acquired at a CT scanner with tilted gantry into “viewing” application and perform 2d measurements there until the software update has been installed. This action has been closed-out on 29/08/2016.

Device

syngo X-Workplace with software VD10E and tabcard ”4D”Siemens
  • Modèle / numéro de série
    syngo X-Workplace with software VD10E and tabcard ”4D”Siemens Material Numbers: 105025522 and 10281299ARTG Number: 160941
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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