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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

DreamStation CPAP and BiPAP Machines Recalled for Programming Error

Agency Publication Date: August 8, 2025
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Summary

Philips Respironics is recalling approximately 93 DreamStation Auto CPAP, DreamStation Auto BiPAP, and DreamStation Auto non-continuous ventilators. These devices may have a programming error that causes them to be configured incorrectly, meaning the machine settings might not match the patient's prescription. This recall affects specific serial numbers for models UDSX500S11F, UDSX700S11F, and UFRX500S14.

Risk

An incorrect device configuration could lead to therapy that does not match the patient's intended prescription, potentially resulting in respiratory distress or ineffective treatment of sleep apnea or other breathing conditions.

What You Should Do

  1. This recall affects Philips DreamStation Auto CPAP (model UDSX500S11F), DreamStation Auto BiPAP (model UDSX700S11F), and DreamStation Auto (model UFRX500S14) non-continuous ventilators.
  2. Identify if your device is affected by checking the model number and serial number on the manufacturer's label located on the bottom of the machine. See the Affected Products section below for the full list of affected codes.
  3. Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Philips Respironics for further instructions.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: DreamStation Auto CPAP. Non-Continuous Ventilator.
Model / REF:
UDSX500S11F
Serial Numbers (57):
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
UDI:
606959429765
Product: DreamStation Auto BiPAP. Non-Continuous Ventilator.
Model / REF:
UDSX700S11F
Serial Numbers:
J18909076CC90
J2091514323C5
J2164570462CB
J23391208BCBE
J26552747A030
J2909781691D2
J294724447698
J301490021E77
UDI:
606959429772
Product: DreamStation Auto. Non-Continuous Ventilator.
Model / REF:
UFRX500S14
Serial Numbers:
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
UDI:
606959069824

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97191
Status: Active
Manufacturer: Philips Respironics, Inc.
Sold By: Medical equipment suppliers; Authorized dealers
Manufactured In: United States
Units Affected: 3 products (57 units; 8 units; 28 units)
Distributed To: Alabama, California, Colorado, Florida, Georgia, Indiana, Louisiana, Maryland, Nebraska, New Jersey, New York, Pennsylvania, Texas, District of Columbia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.