Events

Rappel de MERGE EYE STATION

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

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
    47888
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-12-01
  • 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
    This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an eye station user. in the current workflow a user can select to delete a record(s). when that selection is made a confirmation box is presented asking the user if they want to delete the record(s). the user can then either left click on "ok" or press the "enter" key to confirm the action. currently this confirmation defaults to "ok" or "yes". in this workflow a user could inadvertently hit the "enter" key which would delete the images or procedures. once these images or procedures are deleted they are lost permanently with no recovery.

Device

MERGE EYE STATION
  • Modèle / numéro de série
    Model Catalog: MERGE EYE STATION (Lot serial: 11.3.0); Model Catalog: MERGE EYE STATION (Lot serial: 11.2.1); Model Catalog: MERGE EYE STATION (Lot serial: 10.6); Model Catalog: MERGE EYE STATION (Lot serial: 11.3.1); Model Catalog: MERGE EYE STATION (Lot serial: 11.5); Model Catalog: MERGE EYE STATION (Lot serial: 11.3.2); Model Catalog: MERGE EYE STATION (Lot serial: 11.4); Model Catalog: MERGE EYE STATION (Lot serial: 11.6.0); Model Catalog: MERGE EYE STATION (Lot serial: 11.2.0)
  • Description du dispositif
    Merge Eye Station
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED