Events

Recall of PERFECTO2

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INVACARE CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29338
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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)
  • Product Description
    INVACARE PERFECTO2
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION