Events

Recall of AUTO ICON

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
    34484
  • Event Risk Class
    II
  • Event Initiated Date
    2011-09-30
  • 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
    Communication issue between the icon cpap and the infosmart software there may be instances where changes in prescription settings using the infosmart software via the smartstick may not synchronize with the icon cpap.

Device

AUTO ICON
  • Model / Serial
    Model Catalog: ICONAAN (Lot serial: 101101 TO 110517); Model Catalog: ICONPBN (Lot serial: 100630 TO 110511)
  • Product Description
    AUTO ICON
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.