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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-01118-1
Product Name/Description	BiPAP A40 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)
Recall Action Level	Consumer
Recall Action Classification	Class I
Recall Action Commencement Date	16/08/2022
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	Philips Respironics has determined that certain devices were built with motor assemblies that could contain non-conforming plastic material. The patient may be exposed to the following hazards if the non-conforming material is present: • Exposure to off-gassing not normally present creating a potential biosafety or toxicological hazard. • Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
Recall Action	Recall
Recall Action Instructions	Philips will replace all affected devices. Users will receive new A40 Pro units. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	1800 009 579 - Philips Sleep & Respiratory Care