Events

Rappel de AW VOLUMESHARE 4 - THORACIC VCAR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    91725
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-05-06
  • 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 summary table feature on thoracic vcar to display data incorrect patient name will be displayed if the user does not exit the application in between the analysis of two consecutive patients. if the user did not exit the application the correct imaging study will appear and the data on the summary table will contain the results of the current patient imaging study however the previous patient name will be displayed on the summary table. this summary result may be separated from the remainder of the ct imaging exam if it is printed on film or paper and incorrectly inserted in another patient's file. this issue may cause confusion and possible incorrect assessment. no adverse event has been reported related to this issue.

Device

AW VOLUMESHARE 4 - THORACIC VCAR

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)