Events

Rappel de OHMEDA INFANT WARMER SYSTEM

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
    49974
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-08-09
  • 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
    Hot screws from the "heater head" of the iws could fall onto the bed if the "heater head" assembly has been improperly serviced. this situation can be clinically hazardous because thermal injury to a patient could result. two injuries have been reported as a result of this issue.

Device

OHMEDA INFANT WARMER SYSTEM
  • Modèle / numéro de série
    Model Catalog: 4300 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 4000 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 3500 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 3400 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 3300 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 3100 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 3050 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 3000 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 2001 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 5000 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 4400 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 3051 (Lot serial: >10 CONTACT MANUFACTURER)
  • Description du dispositif
    INFANT WARMER SYSTEM (IWS);Infant Warmer system (IWS)
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)