FDA Device recall Z-1625-2021
BiPAP V30 Auto, US market: 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 V30 Auto, US market: 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-1625-2021 |
| 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 V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
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: N3059246815B4, N305925228752, N30592449378D, N3059251913E9, N30592514C80C, N30592513BCB3, N30592515D985,…Serial Number: N3059246815B4, N305925228752, N30592449378D, N3059251913E9, N30592514C80C, N30592513BCB3, N30592515D985, N305924084164, N305925119FA1, N30592516EB1E, N305925180260, N30592457C72B, N306372301F1F, N306372551C62, N30637223345C, N30592416B1C2, N30592524E264, N30592520A440, N3059252396DB, N30592517FA97, N3059241492D0, N30592512AD3A. |
|---|
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-1625-2021%22
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