Philips Respironics, Inc. medical device recall: DreamStation Auto CPAP. Non-Continuous Ventilator
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97191
- Recall initiated
- Jun 30, 2025
- Classified by FDA
- Aug 8, 2025
- Posted in Enforcement Report
- Aug 20, 2025
- Recalling firm
- Philips Respironics, Inc.
- Firm location
- Murrysville, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Telephone
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Devices may possess a programming error resulting in an incorrect device configuration.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jun 30, 2025. FDA classified it 39 days later, on Aug 8, 2025. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX & DC. The country of France. Philips Respironics, Inc. has 27 recalls in our records.
Recalled products (3)
Z-2227-2025 Class I Ongoing
DreamStation Auto CPAP. Non-Continuous Ventilator.
Codes / lots: 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, J24858283A8C3, J24994323EB40, J2529261301FF, J2543728920D9, J254401628C83, J25467463E51E, J25493556DA17, J254990254097, J255312624BAB, J256278994969, J25782569130A, J257828377BB3, J260977942F33, J2617246993BE, J26312750F8BD, J263183345586, J26751119CCB4, J27018735B4C6, J270987383503, J271152226FB8, J27220570C1F1, J27464550B547, J275917117696, J277824942640, J282846981F7D, J28582229DE76, J2901054169AB, J2902459395E1, J2921836070C5, J29746839268B, J2982204155F4, J299187060F67, J29925204838B, J299567590A7A, J2997189741CA, J30005981C03D, J301116505688, J3067824786A4,…
Quantity: 57 units
Z-2228-2025 Class I Ongoing
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Codes / lots: Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.
Quantity: 8 units
Z-2229-2025 Class I Ongoing
DreamStation Auto. Non-Continuous Ventilator.
Codes / lots: 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.
Quantity: 28 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97191
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.