Events

Rappel de CARESTATION 650

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
    66825
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-05-16
  • 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
    Ge healthcare has recently become aware of a potential safety issue with the carestation 620 650 and 650c. an unexpected transition to a system malfunction state can occur on the carestation 600 series systems. when this does occur you will see this message displayed on the screen: "system malfunction internal problem prevents normal operation. use backup ventilation. to restart turn power off and on." if the system malfunction is left unresolved it could result in loss of mechanical patient ventilation which could lead to hypoxia.

Device

CARESTATION 650
  • Modèle / numéro de série
    Model Catalog: 1012-9650-000 (Lot serial: SM716430070MA); Model Catalog: 1012-9650-000 (Lot serial: SM717020049MA); Model Catalog: 1012-9650-000 (Lot serial: SM716200045MA); Model Catalog: 1012-9650-000 (Lot serial: SM717100033MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080059MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080058MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080057MA); Model Catalog: 1012-9650-000 (Lot serial: SM717080056MA); Model Catalog: 1012-9650-000 (Lot serial: SM717100036MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100027MA); Model Catalog: 1012-9620-000 (Lot serial: SM616430026MA); Model Catalog: 1012-9620-000 (Lot serial: SM616310029MA); Model Catalog: 1012-9620-000 (Lot serial: SM616430025MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100155MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100018MA); Model Catalog: 1012-9620-000 (Lot serial: SM616310012MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100026MA); Model Catalog: 1012-9620-000 (Lot ser
  • Description du dispositif
    CARESTATION 650;CARESTATION 620
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)