Events

Rappel de EASYLINK INFORMATICS SYSTEM V3

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
    26036
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-12-07
  • 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
    When using the easylink quality control package qc results may be unexpectedly associated with a pending control. when this situation occurs pending qc controls may be created or reused. these pending qc controls are not used to evaluate whether the qc result has violated a qc rule therefore qc status may not be flagged appropriately. in addition patient results that were intended to be held through qc-related auto-verification rules may be released to the laboratory information system without appropriate intervention. systems that are using the laboratory information system or another application to manage qc results may see similar behavior transferred to the other systems. this behavior can be experienced under two different circumstances each with a different potential resolution.

Device

EASYLINK INFORMATICS SYSTEM V3
  • Modèle / numéro de série
    Model Catalog: 1000034805 (Lot serial: )
  • Description du dispositif
    EASYLINK INFORMATICS SYSTEM V5.0
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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