Events

Recall of Auto CPAP Humidifiers - FPH NZ

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
    22728
  • Event Initiated Date
    2018-03-20
  • 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 has identified a firmware issue specific to sleepstyle™ units with firmware version v1.1.0 that may impact recording of clinical data and delay remote prescription changes. this issue does not prevent the ongoing delivery of currently prescribed settings and therapy.
  • Action
    Software to be upgraded

Device

Auto CPAP Humidifiers - FPH NZ
  • Model / Serial
    Model: SleepStyle AutoCPAP with Modem Lot 2100199626 - 2100401417, SleepStyle Auto CPAP Batch 2100204218 - 2100291595, SleepStyle CPAPwith Modem Batch 2100194431 - 2100302650, SleepStyle CPAP Batch 2100209577 - 2100405772, Affected:
  • Manufacturer
    Fisher and Paykel Healthcare Ltd

Manufacturer

Fisher and Paykel Healthcare Ltd