FDA-Device2025-08-20Class I

DreamStation Auto CPAP. Non-Continuous Ventilator.

Philips Respironics, Inc.
Hazard

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

Sold states
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.
Affected count
57 units
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
DreamStation Auto CPAP. Non-Continuous Ventilator.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2227-2025

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