FDA Device recall Z-2228-2025
DreamStation Auto BiPAP. Non-Continuous Ventilator
- FDA Device
- Class I
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class I recall of DreamStation Auto BiPAP. Non-Continuous Ventilator by Philips Respironics, citing devices may possess a programming error resulting in an incorrect device configuration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2228-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-06-30 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Reason
Devices may possess a programming error resulting in an incorrect device configuration.
Identifiers
| code_info | Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552…Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2228-2025%22
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