OECDReference EN/AU/PS1104297
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
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- 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
Official information
Risk and measures
- Risk or hazard
- The power cord supplied in affected products does not comply with requirements in the Medical electrical equipment standard IEC60601-1. The power cord supplied may not withstand humidity and mechanical stresses to the same level of the required cord.
- Recommendations
- 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
Official information
Economic operators
- Manufacturer
- Philips Electronics Australia Ltd
Territory
Geography
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
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