Events

Rappel de BUBBLE CPAP SYSTEM - COMPONENTS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par FISHER AND PAYKEL HEALTHCARE LTD..

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
    90251
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-04-12
  • 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
    Fph (fisher & paykel healthcare) introduced a new version of nasal cpap prongs in 2013. since the release of this new version pfh has received reports of the affected prongs detaching from the nasal tubing is not affected by this recall.

Device

BUBBLE CPAP SYSTEM - COMPONENTS
  • Modèle / numéro de série
    Model Catalog: BC492-SK (Lot serial: 131007-140325); Model Catalog: BC491-SK (Lot serial: 131007-140325); Model Catalog: BC490-SK (Lot serial: 131007-140325); Model Catalog: BC471-SK (Lot serial: 131007-140325); Model Catalog: BC461-SK (Lot serial: 131007-140325); Model Catalog: BC5550-10 (Lot serial: 14031203XX-14032503XX); Model Catalog: BC6070-10 (Lot serial: 14031203XX-14032503XX); Model Catalog: BC5560-10 (Lot serial: 14031203XX-14032503XX); Model Catalog: BC5050-10 (Lot serial: 14031203XX-14032503XX); Model Catalog: BC5040-10 (Lot serial: 14031203XX-14032503XX); Model Catalog: BC4540-10 (Lot serial: 14031203XX-14032503XX); Model Catalog: BC4030-10 (Lot serial: 14031203XX-14032503XX); Model Catalog: BC3520-10 (Lot serial: 14031203XX-14032503XX); Model Catalog: BC3020-10 (Lot serial: 14031203XX-14032503XX); Model Catalog: BC6570-10 (Lot serial: 14022603XX-14032503XX); Model Catalog: BC6060-10 (Lot serial: 14022603XX-14032503XX); Model Catalog: BC5550-10 (Lot serial: 14022603XX-14032503XX); Model Catalog:
  • Description du dispositif
    BUBBLE CPAP SYSTEM - COMPONENTS
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.