Events

Rappel de syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and communication 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 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-2014-RN-00287-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-07
  • 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-2014-RN-00287-1
  • 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
    A software error could allow for two different patients to be displayed in syngo dynamics where, images shown for one patient and reporting system data (worksheet and/or report) shown for a different patient potentially resulting in misdiagnosis due to mix-up in patient data. when this error occurs, a previously opened study is not properly disconnected from the sensis hemodynamics system. only customers using sensis-syngo dynamics integration will face the occasional probability of this error occurring.
  • Action
    demographics to review the image toolbar and reporting system, and to ensure that toolbar "auto-hide" is disabled. If a patient mismatch is observed, users are advised to close and reopen the study. A software update will be implemented as a corrective measure. This action has been closed-out on 29/01/2016.

Device

syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and co...
  • Modèle / numéro de série
    syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and communication system)ARTG Number: 120332
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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