Events

Rappel de CARESCAPE R860

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
    78518
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-07-28
  • 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
    The following issue is being addressed by ge healthcare file no. fmi 34066: the evair component manufacturer imtmedical ag is conducting a field corrective action. imtmedical has identified that potential friction of cables and tubing internal to the evair compressor may result in an inability for the compressor to output compressed air. there is a potential for temporary oversupply of oxygen to the patient as a result of this failure because the ge healthcare ventilators are designed to ventilate with 100% oxygen in the case of loss of input air supply pressure.

Device

CARESCAPE R860

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)