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Software issue that results in the display of outdated information.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.