Class II

Medical Device Recall: IntelliSpace Cardiovascular, Software 8.0.0.4.

Philips Medical Systems Nederland B.V. · August 8, 2025

Reason for Recall

Software issue that results in the display of outdated information.

Distribution

US Nationwide distribution in the states of GA, NC & TX.

States Affected

NATIONWIDE

Quantity Affected

4 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2543-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.