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
    98371
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2018-01-11
  • 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
    The manufacturer has identified a limitation within the syngo.Via vb20a reporting sections. after entering the findings information using the findings assistant or the interactive findings dialogue (ifd) user may check the finding information within the report. in case a correction of finding information should be needed user does the correction in "findings information" section or "summary of measured findings" section. in vb20a versions listed this feature is not working as expected: the corrected values modified in the report are neither saved nor printed nor sent to information system. the system will still use the former values. if the late modifications done on the syngo.Via evidence report are not noticed later when creating the formal report in the reporting system outdated information could be sent to the referring physician.

Device

SYNGO.VIA
  • Modèle / numéro de série
    Model Catalog: 10496180 (Lot serial: 101689); Model Catalog: 10496180 (Lot serial: 101928); Model Catalog: 10496180 (Lot serial: 101568); Model Catalog: 10496180 (Lot serial: 101386); Model Catalog: 10496180 (Lot serial: 109939); Model Catalog: 10496180 (Lot serial: 101075); Model Catalog: 10496180 (Lot serial: 131196); Model Catalog: 10496180 (Lot serial: 101414); Model Catalog: 10496180 (Lot serial: 101401); Model Catalog: 10496180 (Lot serial: 130766); Model Catalog: 10496180 (Lot serial: 101511); Model Catalog: 10496180 (Lot serial: 131273); Model Catalog: 10496180 (Lot serial: 130294); Model Catalog: 10496180 (Lot serial: 222377); Model Catalog: 10496180 (Lot serial: 102241); Model Catalog: 10496180 (Lot serial: 130666)
  • 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