FDA Medical Device · Z-2228-2025

DreamStation Auto BiPAP. Non-Continuous Ventilator.

Class I · Ongoing

Devices may possess a programming error resulting in an incorrect device configuration.

Affected lots / codes — check yours against thisModel No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.

Recalling firm: Philips Respironics, Inc., Murrysville, PA
Classification: Class I (most serious — risk of serious harm)
Status: Ongoing
Quantity: 8 units
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 initiated: June 30, 2025
Classified: August 8, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2228-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →