FDA Device recall Z-1628-2021
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting
- FDA Device
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting by Philips Respironics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1628-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-06 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
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.
Identifiers
| code_info | Serial Number: V305622168DB9, V30562335D64E, V305626872849, V30562903EA6A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1628-2021%22
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