Events

Rappel de SYNGO.PLAZA

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
    81987
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-02-20
  • 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
    A customer safety advisory notice is being issued to inform customers about a potential issue when using syngo.Plaza. when using the pre-fetch/retrieve functionality from the archive (long term storage (lts)) for a study where all the series have not yet been archived (e.G. due to late received series or archival time-out) these non-archived series will incorrectly get an archive flag set but will be protected from deletion. therefore it is possible that a user can manually remove the deletion protection in the short term storage (sts) from these non-archived series due to the impression that the whole study has been archived based on the archive flag being set. in this situation there will be a partial data loss for the affected study.

Device

SYNGO.PLAZA
  • Modèle / numéro de série
    Model Catalog: 10592457 (Lot serial: 100001)
  • Description du dispositif
    SYNGO.PLAZA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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