Z-1630-2021 Class II Terminated
FDA device recall Z-1630-2021 was initiated by Philips Respironics, Inc. on April 6, 2021 and is designated Class II. 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 … The recall status is terminated (terminated January 17, 2024). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 2, 2021
- Initiation Date
- April 6, 2021
- Termination Date
- January 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
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.
Distribution Pattern
Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan
Code Information
Serial Number: V306120599B37, V3061207124CF, V30612105753F, V306121267414