Events

Rappel de CARESTATION 620

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
    19854
  • 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 incomplete seal can exist between the disposable absorber and the breathing circuit lower assembly of the carestation 600 series systems. this incomplete seal can allow rebreathing of patient gases that have bypassed the carbon dioxide (co2) absorbent material and could result in unintended elevated inspired levels of co2 (fico2) which could lead to hypercarbia.

Device

CARESTATION 620
  • Modèle / numéro de série
    Model Catalog: 1012-9620-000 (Lot serial: SM617100027MA); Model Catalog: 1012-9620-000 (Lot serial: SM616430026MA); Model Catalog: 1012-9620-000 (Lot serial: SM616200018MA); Model Catalog: 1012-9620-000 (Lot serial: SM616430025MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100026MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100018MA); Model Catalog: 1012-9620-000 (Lot serial: SM616310012MA); Model Catalog: 1012-9620-000 (Lot serial: SM616310029MA); Model Catalog: 1012-9620-000 (Lot serial: SM617100155MA); 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: SM717100036MA); 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 ser
  • Description du dispositif
    CARESTATION 620;CARESTATION 650
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)