BiPAP A40 System Silver recall
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Why was BiPAP A40 System Silver 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number: V30562261B40E
- Product
- BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 1 unit
- Distribution
- Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan
- Recall date
- June 2, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)