Events

Rappel de MERGE PACS

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
    127903
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-07-29
  • 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 merge pacs inability to display presentation states on prior comparison studies generated on 3rd party systems or that have been migrated from office pacs. pacs 6.5.6 introduced the feature to be able to display foreign presentation states however this feature was only available on the primary study in any given viewer instance. it did not apply to prior comparison studies that were opened in the same viewer. users might assume that if the annotations are available in the primary study they would also be shown if available on the prior comparison studies.

Device

MERGE PACS
  • Modèle / numéro de série
    Model Catalog: MERGE PACS (Lot serial: 6.6.1); Model Catalog: MERGE PACS (Lot serial: 6.5.5); Model Catalog: MERGE PACS (Lot serial: 6.6.0); Model Catalog: MERGE PACS (Lot serial: 6.6.1.1); Model Catalog: MERGE PACS (Lot serial: 6.6.2); Model Catalog: MERGE PACS (Lot serial: 6.5.9); Model Catalog: MERGE PACS (Lot serial: 6.5.6); Model Catalog: MERGE PACS (Lot serial: 6.5.7); Model Catalog: MERGE PACS (Lot serial: 6.5.8)
  • Description du dispositif
    Merge PACS
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED