Medical device recalls Moderate risk

Philips North America recalls Cardiac Workstation 5000; Model Number: 860439;

Recall date
September 12, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0165-2026
FDA classification
Class II
Brand / firm
Philips North America
Sold / distributed
US Nationwide distribution in the states of CA, IA, TN, TX, VA.

Why it was recalled

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cardiac Workstation 5000; Model Number: 860439;

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