DreamStation Auto BiPAP. Non-Continuous Ventilator.
Pending LLM rewrite. Source: FDA_DEVICE Z-2228-2025.
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 BiPAP. 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 (10)
- Model No. UDSX700S11F
- UDI: 606959429772
- Serial No. J18909076CC90
- J2091514323C5
- J2164570462CB
- J23391208BCBE
- J26552747A030
- J2909781691D2
- J294724447698
- J301490021E77.
Distribution
Distributed nationwide across the United States.
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