Events

Recall of ICON+ PREMO CPAP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FISHER AND PAYKEL HEALTHCARE LTD..

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
    23607
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-23
  • 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
    Fph has become aware that there is a potential power issue on certain icon cpap units. these icon cpap units could potentially become inoperable which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.

Device

ICON+ PREMO CPAP
  • Model / Serial
    Model Catalog: ICONPBN-HT (Lot serial: 121219); Model Catalog: ICONPBN (Lot serial: 121219); Model Catalog: ICONPBN-HTC (Lot serial: 121218); Model Catalog: ICONPBN-HT (Lot serial: 121218); Model Catalog: ICONPBN (Lot serial: 121218); Model Catalog: ICONPBN-HTC (Lot serial: 121215); Model Catalog: ICONPBN-HT (Lot serial: 121215); Model Catalog: ICONPBN (Lot serial: 121215); Model Catalog: ICONPBN-HTC (Lot serial: 121213); Model Catalog: ICONPBN-HT (Lot serial: 121213); Model Catalog: ICONPBN (Lot serial: 121213); Model Catalog: ICONPBN-HTC (Lot serial: 121211); Model Catalog: ICONPBN-HT (Lot serial: 121211); Model Catalog: ICONPBN (Lot serial: 121211); Model Catalog: ICONPBN-HTC (Lot serial: 121210); Model Catalog: ICONPBN-HT (Lot serial: 121210); Model Catalog: ICONPBN (Lot serial: 121210); Model Catalog: ICONPBN-HTC (Lot serial: 121219); Model Catalog: ICONPBN (Lot serial: 121220); Model Catalog: ICONPBN-HT (Lot serial: 121220); Model Catalog: ICONPBN-HTC (Lot serial: 121220); Model Catalog: ICONPBN (Lot s
  • Product Description
    ICON+ PREMO CPAP
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.