DreamStation Auto. Non-Continuous Ventilator recall
DreamStation Auto. Non-Continuous Ventilator.
Why was DreamStation Auto. Non-Continuous Ventilator recalled?
Devices may possess a programming error resulting in an incorrect device configuration.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- Product
- DreamStation Auto. Non-Continuous Ventilator.
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 28 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 date
- August 20, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)