FDA-Device2021-06-02Class II
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Philips Respironics, Inc.
Hazard
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.
Sold states
Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan
Affected count
1 unit
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1627-2021Don't want to check this manually?
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