Events

Rappel de SYNGO.VIA

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE LIMITED.

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
    78053
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-09-19
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Siemens is providing an update package for all systems running on syngo.Via software version va20. this resolves issues encountered with the following software applications: syngo.Via ct - in workflows that contain the mm reading workflow step especially ct neuro perfusion and ct dynamic angio data may not have been loaded to the mm reading workflow step if the data set was assigned to such a workflow scanner site. - in ct bone reading the edit rib function did not work properly: after scrolling multiple times in an mpr image the marker disappeared and after editing a centerline multiple times the edited rib was not correctly displayed in the unfolded rib view. - in ct coronary analysis heart segmentation in vrt images may have been of poor quality as some parts of the heart were missing. - in ct cardiac function the identification of the annular plane did not work in pediatric studies although the system confirmed a completion of preprocessing preprocessing was not completed. syngo.Via mr - in the neuro perfusion workflow the task "remaining images" was missing. therefore it could happen that some series were not available in the workflow. syngo.Via mi - in mm oncology editing a contour could lead to an erroneous segmentation.

Device

SYNGO.VIA
  • Modèle / numéro de série
    Model Catalog: 10496180 (Lot serial: LOT/SN: 100778 101414 101963)
  • Description du dispositif
    SYNGO.VIA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC