IntelliSpace Cardiovascular, Software 8.0.0.4.
FDA Recall #Z-2543-2025 — Class II — August 8, 2025
Product Description
IntelliSpace Cardiovascular, Software 8.0.0.4.
Reason for Recall
Software issue that results in the display of outdated information.
Recalling Firm
Philips Medical Systems Nederland B.V. — Eindhoven, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4 units
Distribution
US Nationwide distribution in the states of GA, NC & TX.
Code Information
Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.