Events

Rappel de syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (radiology information system used to process data)

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-2013-RN-00303-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-05
  • 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-2013-RN-00303-1
  • 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
    If procedures requested have been deleted or changed (eg. because a procedure was replaced by a better fitting one in syngo workflow browser or portal radiologist), and the clinical information (risk factors, lab values, reason, diagnosis) was changed after the procedure was changed, then outdated clinical information (risk factors, lab values, reason, diagnosis) could be displayed in the user interface and saved (reason is that the outdated procedure with the outdated clinical information is used).
  • Action
    Siemens is providing users with work around instructions to prevent the problem occurring and is also developing a software correction to permanently correct the problem.

Device

syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (...
  • Modèle / numéro de série
    syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (radiology information system used to process data)ARTG Number: 184557
  • Manufacturer
    Siemens Ltd

Manufacturer

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