Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22728
Brand Name:Auto CPAP Humidifiers - FPH NZ
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:
Software version:
Recalling Organisation:Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki
AUCKLAND 2013
Contact Information:0800 503 553
Manufacturer:Fisher & Paykel Healthcare Ltd
Brand Name:CPAP Humidifiers - FPH NZ
Model:SleepStyle CPAP with Modem SPSABA, SleepStyle CPAP SPSCBA
Affected:
Software version:
Recalling Organisation:Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki
AUCKLAND 2013
Contact Information:0800 503 553
Manufacturer:Fisher & Paykel Healthcare Ltd
Issue: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.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Retail
Date Commenced:20/3/2018
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