Events

Rappel de INTELEPACS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par INTELERAD MEDICAL SYSTEMS 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
    139011
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-11-30
  • 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
    Following a complaint from a client intelerad is taking a pro-active field action to prevent occurrence of a possible patient safety problem at client sites. the issue is triggered by the presence of the "less than" character (<) in the report. when viewing a report the "less than" character is not present while it was there in the original report received by intelepacs. in other cases when the character is present in a combination with other characters parts of the report text following the less than character are not displayed depending on the intelerad application used by the end-user to review the reports.

Device

INTELEPACS

Manufacturer

INTELERAD MEDICAL SYSTEMS INCORPORATED