Events

Rappel de PERFECTO2

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par INVACARE CORPORATION.

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
    29338
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-12-22
  • 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
    Invacare has learned that the psi (pressure sensitive interrupter) designed for the compressor motor start/run capacitor by one supplier could lead to rupture. that capacitor in the oxygen concentrator has an internal pressure relief component (the psi) which may not operate as intended permitting the capacitor to rupture in certain circumstances. if the psi does not function to relieve the heat and pressure due to a short circuit within the capacitor then the pressure can cause a rupture in the seam between the housing and the end plate. if the rupture occurs the oil may be expelled from the capcitor which may result in a fire hazard.

Device

PERFECTO2
  • Modèle / numéro de série
    Model Catalog: IRC9LXO2AWQN (Lot serial: 10FSZ470209); Model Catalog: IRC5PO2 (Lot serial: 10FSZ470209); Model Catalog: IRC5P (Lot serial: 10FSZ470209); Model Catalog: IRC9LXO2AWQN (Lot serial: 10HSZ470004); Model Catalog: IRC5PO2 (Lot serial: 10HSZ470004); Model Catalog: IRC5P (Lot serial: 10HSZ470004); Model Catalog: IRC9LXO2AWQN (Lot serial: 10ISZ470005); Model Catalog: IRC5PO2 (Lot serial: 10ISZ470005); Model Catalog: IRC5P (Lot serial: 10ISZ470005); Model Catalog: IRC9LXO2AWQN (Lot serial: 10ISZ470051); Model Catalog: IRC5PO2 (Lot serial: 10ISZ470051); Model Catalog: IRC5P (Lot serial: 10ISZ470051); Model Catalog: IRC9LXO2AWQN (Lot serial: 10CSZ43XXXX - 12GSZ62XXXX); Model Catalog: IRC5PO2 (Lot serial: 10CSZ43XXXX - 12GSZ62XXXX); Model Catalog: IRC5P (Lot serial: 10CSZ43XXXX - 12GSZ62XXXX)
  • Description du dispositif
    INVACARE PERFECTO2
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION