[pending] DreamStation Auto CPAP. Non-Continuous Ventilator.
Pending LLM rewrite. Source: FDA_DEVICE Z-2227-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03