AU recall: Philips BiPAP A40 – non-conforming materials could cause off-gassing or device failure
A recall has been issued in Australia for Philips bi-level positive airway pressure (BiPAP) A40 non-invasive ventilators with the following serial numbers:
- V2887246677A0
- V288724698F57
- V28872472285C
- V288724777FF1
- V28872479968F
- V288724808886
- V28872485DF2B
- V28872492B24C
- V28872495C6F3
- V288724981D16
- V288725010D13
- V2887251114CB
- V2887251771FD
These units may have been manufactured with non-conforming plastic materials in the motor assembly. Potential hazards from the non-conforming materials are:
- biosafety or toxicological hazard from off-gassing.
- sudden device failure, which could lead to patient asphyxia if not immediately identified and addressed.
Philips advises it will replace all affected devices with a new A40 Pro unit.
For more information, see the Therapeutic Goods Administration Australia recall listing.
At the time of writing, no recall is listed with Medsafe New Zealand.