medical Class II Updated 2021-06-02

Philips Respironics, Inc. recalls BiPAP A30, Brazil: Continuous ventilator, non-life-supportin

Recalled Product

BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143


Hazard / Issue

Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. 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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Number: N306151248079, N306164395E34
View official government recall

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