BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
Reported: June 2, 2021 Initiated: April 6, 2021 #Z-1626-2021
Product Description
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
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.
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 10 units
- Distribution
- Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169. Recalled by Philips Respironics, Inc.. Units affected: 10 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 2, 2021. Severity: Moderate. Recall number: Z-1626-2021.
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