Medical device recalls Moderate risk

Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular, Software 8.0.0.4.

Recall date
August 8, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2543-2025
FDA classification
Class II
Brand / firm
Philips Medical Systems Nederland B.V.
Sold / distributed
US Nationwide distribution in the states of GA, NC & TX.

Why it was recalled

Software issue that results in the display of outdated information.

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

What was recalled

IntelliSpace Cardiovascular, Software 8.0.0.4.

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