CLASS I ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report

DreamStation Auto recalled by Philips Respironics

Philips Respironics is recalling DreamStation Auto, distributed nationwide in the US. The recall was initiated on 30 Jun 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel 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 recalled28 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2229-2025
FDA event ID: 97191
Recalling firm: Philips Respironics, Murrysville, PA
Classification: Class I
Status: Ongoing
Recall initiated: 30 Jun 2025
FDA classified: 8 Aug 2025
Reported: 20 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

30 Jun 2025	Recall initiated by company
8 Aug 2025	Classified by FDA	+39 days
20 Aug 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

DreamStation Auto. Non-Continuous Ventilator.

Where it was distributed

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.

Nationwide Alabama California Colorado District of Columbia Florida Georgia Indiana Louisiana Maryland Nebraska New Jersey New York Pennsylvania Texas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

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 should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 97191

This product is part of a recall event; the main page for the event is DreamStation Auto BiPAP recalled by Philips Respironics.

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025	CLASS I	DreamStation Auto BiPAP recalled by Philips Respironics	Philips Respironics	Other	Nationwide
20 Aug 2025	CLASS I	DreamStation Auto CPAP recalled by Philips Respironics	Philips Respironics	Other	Nationwide

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