BiPAP A40 Ventilator
Reason for Recall / Hazard
Certain devices were built with motor assemblies that may contain non-conforming plastic material.
Product Description & Identification
Reason / Defects: Certain devices were built with motor assemblies that may contain non-conforming plastic material. Hazards: 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 to 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.
Affected Products
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)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 5a23c526-b9a7-43d4-aa8c-66f2215bfff9 |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/bipap-a40-ventilator |
| Pub Date | Tue, 30 Aug 2022 00:00:00 +0000 |
| Extracted image | https://www.productsafety.gov.au/system/files/styles/large/private/Philips%20BiPAP%20A40%20Ventilator.jpg?itok=OYVu0cx2 |