FDAHealthJune 30, 2025

Philips Respironics, Inc. — DreamStation Auto BiPAP. Non-Continuous Ventilator.

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: June 30, 2025

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.

What's affected?

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

Additional details

Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 8 units.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.