Events

Recall of F&P SLEEPSTYLE AUTO CPAP WITH MODEM

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
    82461
  • Event Risk Class
    III
  • Event Initiated Date
    2018-03-14
  • 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
    A firmware anomaly prevents the f&p sleepstylet from recording clinical data and may delay remote prescription changes if the device is continually powered for 20-50 days. this timeframe may vary depending on the number and length of therapy sessions.

Device

F&P SLEEPSTYLE AUTO CPAP WITH MODEM
  • Model / Serial
    Model Catalog: SPSAAN (Lot serial: >10 CONTACT COMPANY)
  • Product Description
    F&P SLEEPSTYLE CPAP DEVICE
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.