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Use caution Medical device recall · FDA · Published June 30, 2025

Philips DreamStation Auto BiPAP Recall: Programming Error Hazard

Philips Respironics recalls a small number of DreamStation Auto BiPAP non-continuous ventilators due to a programming error causing incorrect device configuration.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2228-2025Medical devicePhilips Respironics ›
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Contact the company

Recalling firmPhilips Respironics, Inc.1001 Murry Ridge Ln · Murrysville, PA 15668-8517
✎ GovInfoNow plain-language explainer

Philips Respironics, Inc. is recalling the DreamStation Auto BiPAP non-continuous ventilator because the devices may have a programming error that results in an incorrect device configuration. This recall affects only eight units distributed worldwide, including specific U.S. states and France. The record does not specify what the incorrect configuration entails or the potential health consequences of this error. Read more at govinfonow.com/recall/51929-philips-respironics-dreamstation-auto-bipap-recall-programming-error-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/51929-philips-respironics-dreamstation-auto-bipap-recall-programming-error-risk · Updated October 13, 2026 · FDA enforcement record: FDA #Z-2228-2025

Cite this page

“Philips DreamStation Auto BiPAP Recall: Programming Error Hazard.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/51929-philips-respironics-dreamstation-auto-bipap-recall-programming-error-risk. Based on FDA recall #Z-2228-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2228-2025%22&limit=1).

The FDA announced on June 30, 2025, that Philips Respironics, Inc. is voluntarily recalling DreamStation Auto BiPAP Non-Continuous Ventilators due to a programming error causing incorrect device configuration. The agency issued recall number Z-2228-2025 for the Class I recall.

How to tell if you have it

  • Brand: Philips Respironics
  • Product: DreamStation Auto BiPAP. Non-Continuous Ventilator
  • Model No.: UDSX700S11F
  • UDI: 606959429772
  • Serial Nos.: J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77

The hazard

According to the FDA, the devices may possess a programming error resulting in an incorrect device configuration. The recall affects 8 units distributed worldwide and in the U.S. states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX, DC, and France.

Context

GovInfoNow's records show Philips Respironics, Inc. has 25 other recalls on record since June 12, 2018. Recent brand recalls include the March 2, 2026 Trilogy Evo Ventilator Software Issue regarding obstruction alarms and tidal volume discrepancies, as well as the October 7, 2025 SimplyGo Mini Battery Kit Recall for defective chips causing oxygen shutdown. Other recent recalls of similar products include the Draeger Atlan A350XL Anesthesia Workstation Recall (May 7, 2026), the Baxter Blue Ventilator Adapter Module Recall (February 18, 2026), and the Draeger Atlan A350 Anesthesia Workstation Recall (May 7, 2026).

How to tell if you have this one

Check if you own a Philips Respironics DreamStation Auto BiPAP non-continuous ventilator with Model No. UDSX700S11F. Verify the Serial Number against this list: J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, or J301490021E77. The UDI is 606959429772.

  • Brand
    Philips Respironics
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    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.
Recall numberProduct, codes & lotsQuantity
Z-2227-2025DreamStation Auto CPAP. Non-Continuous Ventilator.; 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, J30982199BB1D.57 units
Z-2228-2025DreamStation Auto BiPAP. Non-Continuous Ventilator.; Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.8 units
Z-2229-2025DreamStation Auto. Non-Continuous Ventilator.; 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, J30708300FB50.28 units

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 13 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Louisiana, Maryland, Nebraska, New Jersey, New York, Pennsylvania, Texas.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Jun 30, 202512. FDA classified it Class I: Aug 8, 202523. Published in FDA’s Enforcement Report: Aug 20, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Philips RespironicsSafeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
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Other Philips Respironics recalls

Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
March 2, 2026Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
March 2, 2026Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of
October 7, 2024Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
March 19, 2024Philips Respironics, Inc. recalls Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B,
May 1, 2023Philips Respironics, Inc. recalls Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B,
March 1, 2023

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2228-2025 (June 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2228-2025 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA