Events

Rappel de syngo Imaging XS and syngo.plaza (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-01235-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-24
  • 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-01235-1
  • 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
    Printouts may be printed in incorrect anatomical size when using syngo imaging xs/ syngo.Plaza filming application to print in anatomical size with a printer not appropriate for anatomical printing. this may happen due to an invalid combination of printer and the printer configuration file.
  • Action
    Only printers identified in the customer letter are validated to be used for anatomical printing. Siemens is recommending users to check their anatomical printouts by using the scale at the right-hand edge of the printout. The distance between two graduation lines corresponds to one centimetre in the anatomy. Please calculate any distances measured on the printout to correspond with this scale prior to printing. If customers have any printer which is not suitable for anatomical printing, they are advised to contact the Siemens Sales Representative. This action has been closed-out on 07/06/2016.

Device

syngo Imaging XS and syngo.plaza (Radiology picture archiving and communication system)
  • Modèle / numéro de série
    syngo Imaging XS and syngo.plaza (Radiology picture archiving and communication system)syngo Imaging XSModel numbers: 7502029 and 10496279, syngo.plaza Model numbers :10863173, 10592457 and 10863171ARTG number: 120332
  • Manufacturer
    Siemens Ltd

Manufacturer

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