Recall Z-1627-2021— Philips Respironics, Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Respironics, Inc., initiated 2021-04-06, terminated 2024-01-17. FDA's recall record names no specific 510(k) clearance for this event. Product: BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177. Reason: 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..
- Recalling firm
- Philips Respironics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-06
- Terminated
- 2024-01-17
- Firm location
- Murrysville, PA, United States
Product description
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.