PRA number
Published date
Product description
BiPAP A40 Ventilator
Serial numbers: V2887246677A0, V288724698F57, V28872472285C, V288724777FF1, V28872479968F, V288724808886, V28872485DF2B, V28872492B24C, V28872495C6F3, V288724981D16, V288725010D13, V2887251114CB and V2887251771FD
ARTG 200289
(Philips Electronics Australia Ltd - Positive airway pressure unit, bi-level)
Reasons the product is recalled
Certain devices were built with motor assemblies that may contain non-conforming plastic material.
The hazards to consumers
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.
What consumers should do
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.
Traders who sold this product
Healthcare facilities in NSW, QLD, SA and WA
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.