BiPAP A40, DreamStation, BiPAP A30, BiPAP Auto System One 60 Series, BiPAP AVAPS...
Reason for Recall / Hazard
The power cord supplied in affected products does not comply with requirements in the Medical electrical equipment standard IEC60601-1.
Product Description & Identification
Reason / Defects: The power cord supplied in affected products does not comply with requirements in the Medical electrical equipment standard IEC60601-1. Hazards: The power cord supplied may not withstand humidity and mechanical stresses to the same level of the required cord. What to 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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | ec60fb22-4538-4e0f-99e9-e5f5d017bb50 |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/bipap-a40-dreamstation-bipap-a30-bipap-auto-system-one-60-series-bipap-avaps-c-series-bipap-a40-pro-trilogy-evo-remstar-simplygo-and-elegance-devices |
| Pub Date | Tue, 20 Dec 2022 00:00:00 +0000 |
| Extracted image | https://www.productsafety.gov.au/system/files/styles/large/private/Dreamstation.jpg?itok=zWYwtKAl |