Events

Recall of INFANT RADIANT WARMERS

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
    93986
  • Event Risk Class
    III
  • Event Initiated Date
    2009-10-21
  • 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
    Notifying users in canada of an updated test procedure for the power-fail alarm of the iw900 series infant radiant warmer. the service manual already includes a requirement for an annual check of the power-fail alarm. the test procedure has been revised to check that the power-fail alarm operates for at least 12 minutes. the revised test procedure accounts for any unexpected degradation over time of the supercapacitor that operates the power-fail alarm.

Device

INFANT RADIANT WARMERS
  • Model / Serial
    Model Catalog: IW910 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW920 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW930 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW932 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW934 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW950 (Lot serial: All Infant Warmers in Canada.); Model Catalog: IW980 (Lot serial: All Infant Warmers in Canada.); Model Catalog: ABOVE SERIES WITH SUFFIX JEU (Lot serial: All Infant Warmers in Canada.)
  • Product Description
    IW900 Series Infant Warmer
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.