PRA number
Published date
Product description
The product list was updated on 1 February 2023 to include additional models.
This recall covers models with power cords that do not comply with requirements in the Medical electrical equipment standard IEC60601-1.
This is separate to recall PRA 2021/19121 - Philips Electronics Australia Ltd — Philips Respironics - Certain CPAP and Bi-Level PAP Devices
Philips Respironics – Sleep & Respiratory Care Devices
BiPAP A40
DreamStation
BiPAP A30
BiPAP Auto System One 60 Series
BiPAP AVAPS C Series
BiPAP A40 Pro
BiPAP A40 EFL
Trilogy Evo
REMstar
SIMPLYGO
Elegance devices
ARTG's 200289, 295664, 133794, 209934, 329407 329408, 295664, 274181, 278352
See attached product list
Reasons the product is recalled
The power cord supplied in affected products does not comply with requirements in the Medical electrical equipment standard IEC60601-1.
The hazards to consumers
The power cord supplied may not withstand humidity and mechanical stresses to the same level of the required cord.
What consumers should do
The device can continue to be used in the home setting with its original IEC52 power cord provided general safety precautions are followed such as:
- Keeping the cords away from high traffic areas
- Holding the plug when pulling the cord from a power socket
- Keeping the cord away from heat sources
For home use devices with detachable power cord consumers that want their power cords replaced please go to https://philips.to/3qGMdB5
For devices with integrated cords (InnoSpire Elegance device) consumers should maintain awareness and follow general safety precautions outlined in the instruction for use. If the power cord is damaged, please contact Philips on 1800 830 517.
For more details see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00980-1
Traders who sold this product
Chemists, Pharmacies and Sleep Clinics
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.