Philips Respironics, Inc. — DreamStation Auto. 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. Non-Continuous Ventilator.
- Lot code
- 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.
Additional details
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.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 28 units.
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