Events

Rappel de SERVER SOFTWARE

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
    32765
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-04-14
  • 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 potential issue when using "in-progress" invasive reporting with sensis integration to syngo dynamics v9.5. the issue occurs under the following conditions: - sensis-syngo dynamics integration - sensis study is opened from syngo dynamics while still "in-progress" - sensis reference numbers > 1000000 -sensis reference numbers grow in response to hl7 messages even if those hl7 messages are not being utilized by sensis and/or syngo dynamics. sensis reference number greater than 1000000 are wrongly modified during transfer to syngo dynamics. when this happens during "in-progress" reporting a study will get a sensis reference number for the wrong study in sensis. this causes an incorrect 'link' between the syngo dynamics images and the sensis study data. if this happens customers will have to call siemens service team. there has not been any patient consequence reported from the installed base.

Device

SERVER SOFTWARE
  • Modèle / numéro de série
    Model Catalog: 10091862 (Lot serial: S/N 85162); Model Catalog: 10091863 (Lot serial: S/N 85182)
  • Description du dispositif
    SERVER SOFTWARE
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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