DreamStation Auto CPAP. Non-Continuous Ventilator.
Pending LLM rewrite. Source: FDA_DEVICE Z-2227-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Devices may possess a programming error resulting in an incorrect device configuration.
The recalled product
- Product
- DreamStation Auto CPAP. Non-Continuous Ventilator.
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. UDSX500S11F
- UDI: 606959429765
- Serial No. J204432084D03
- J206957368810
- J207023218478
- J21450857096A
- J219786492F58
- J222909239F3E
- J22718022B9D6
- J22924665CF8A
- J230303131D07
- J23148826984B
- J23307132CC16
- J2379520271A4
- J23933071851F
- J23963189F617
- J242941498857
- J243763392C02
- J24551698A015
- J247575014664
Distribution
Distributed nationwide across the United States.
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