FDA Device recall Z-2229-2025
DreamStation Auto
- FDA Device
- Class I
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class I recall of DreamStation Auto 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-2229-2025 |
| 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. Non-Continuous Ventilator.
Reason
Devices may possess a programming error resulting in an incorrect device configuration.
Identifiers
| code_info | Model No. UFRX500S14; UDI: 606959069824; Serial No. J19093383C0FD, J195817171415, J195967969739, J1999161223D4, J208714…Model No. UFRX500S14; UDI: 606959069824; Serial No. J19093383C0FD, J195817171415, J195967969739, J1999161223D4, J208714453211, J21638786344A, J216718740A24, J22792026797C, J23016752559D, J23025544A4CA, J235207601E36, J236974697023, J24378890CB57, J24404277EDBB, J251606314EAA, J255220797791, J25755126C4A9, J262274772766, J26263484C9C9, J26377226BCF1, J26525214B253, J2661985603DE, J26673715FBD4, J27099876ED61, J272180530173, J27467764497E, J305016887150, J30708300FB50. |
|---|
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-2229-2025%22
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