Events

Recall of FPH IW900-series Infant Radiant Warmers

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    17640
  • Event Initiated Date
    2014-11-06
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Fisher and Paykel Healthcare Ltd, 15 Maurice Paykel Place, East Tamaki, AUCKLAND 2013
  • Reason
    The manufacturer is recalling selected infant warmers because it has had two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case, however, there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
  • Action
    Product to be modified

Device

FPH IW900-series Infant Radiant Warmers
  • Model / Serial
    Model: Model Numbers: IW910xxx, IW920xxx, IW931xxx, IW932xxx, IW933xxx, IW934xxx, IW951xxx, IW952xxx, IW953xxx, IW954xxx, IW980xxx, IW990xxx, Affected: Date of manufacture: 16- Nov-2007 to 10-Aug-2009
  • Manufacturer
    Fisher and Paykel Healthcare Ltd

Manufacturer

Fisher and Paykel Healthcare Ltd