Events

Rappel de syngo.plaza(Radiology picture archiving/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-2015-RN-00034-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-15
  • 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-00034-1
  • 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
    In the event of a system crash (e.G. bluescreen, power outage) the image may not be written from cache to the file system and may be lost in syngo.Plaza. when a further image is received, syngo.Plaza will allocate the same file name for the new image, and after some internal checks it will add the entry to the database for the new image. this gives rise to two references in the database to the same image which may lead to either:· the wrong image being displayed, which means for that series there is an image with a wrong examination parameter, and/or wrong examination (e.G. head/knee) and/or may be the wrong patient. this patient mix-up could lead to a wrong diagnosis, or· data loss in that an image is missing.To date this issue has not been reported by australian customers.
  • Action
    Siemens is providing a work around for customers whilst a permanent software fix is being developed. This action has been closed-out on 15/07/2016.

Device

syngo.plaza(Radiology picture archiving/communication system)
  • Modèle / numéro de série
    syngo.plaza(Radiology picture archiving/communication system)Lot numbers: 10863171 & 10863173ARTG number: 120332
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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