Medical device recalls High risk

Philips Respironics, Inc. recalls DreamStation Auto. Non-Continuous Ventilator.

Recall date
June 30, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2229-2025
FDA classification
Class I
Brand / firm
Philips Respironics, Inc.
Sold / 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.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

DreamStation Auto. Non-Continuous Ventilator.

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