Philips Respironics, Inc. Recall 87753
Description: BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Philips Respironics, Inc. Recall 87753 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1627-2021 |
| Event ID | 87753 |
| Event Description | BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177 |
| Product Type | Devices |
| Distribution | Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan |
| Quantity | 1 unit |
| Recall 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. |
| Device Classification | 20210602 |
| Device Code Info | Serial Number: V30562261B40E |
| Center Classification Date | 20210521 |
| Recall Initiation Date | 20210406 |
| Recalling Firm | Philips Respironics, Inc. |
| Initial Notification | Letter |
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