| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00250-1 |
| Product Name/Description |
F & P SleepStyle CPAP Device
Devices using V1.1.0 firmware
Model Number; SPSAAA, SPSCAA
Batch Numbers:
SPSAAA: 2100199626 - 2100401417
SPSCAA: 2100194431 - 2100302650
ARGT Number: 227979 (Fisher & Paykel Healthcare - OSA CPAP Therapy devices - Home CPAP unit) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
29/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Fisher & Paykel Healthcare has identified a firmware anomaly which prevents the Fisher & Paykel SleepStyle from recording clinical data, and may delay remote prescription changes if the device is continually powered for 20-50 days. This time frame may vary depending on the number and length of therapy sessions. The firmware anomaly does not prevent the ongoing delivery of currently prescribes setting and therapy does not affect any other functions of the device.
Only devices with V1.1.0 firmware are affected.
To date, no complaints resulting in injury have been received relating to this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Fisher and Paykel will be contacting distributors, hospitals and retailers to arrange for hardware upgrade to be installed in affected units.
For devices currently used in a home setting, this action does not impact products with activated modem capabilities. For affected product without modems, have non-activated modems or modems out of service, continuous data recording can be ensured by reminding users to follow instructions in the SleepStyle Use and Care guide to unplug and clean the device every 7 days.
This action has been closed out on 27/02/2019 |
| Contact Information |
03 9871 4900 - Fisher & Paykel Healthcare |