OECDReference EN/AU/PS1102986
BiPAP A40 Ventilator
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- BiPAP A40 Ventilator
Official information
Risk and measures
- Risk or hazard
- Certain devices were built with motor assemblies that may contain non-conforming plastic material. If the non-conforming material is present patients may be exposed to: 1. Chemical exposure due to off-gassing, creating a potential biosafety or toxicological hazard. 2. Sudden failure of the device causing a Ventilator Inoperative condition, which may result in asphyxia if not immediately identified and addressed by the care provider.
- Recommendations
- Philips will replace all the affected devices, users will receive new A40 Pro units. For more details, see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01118-1 If you believe your product is affected and you have not received a letter from Philips, please contact Philips Sleep and Respiratory Care by phone on 1800 009 579.
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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