FDA-Device2025-09-17Class II
IntelliSpace Cardiovascular, Software 8.0.0.4.
Philips Medical Systems Nederland B.V.
Hazard
Software issue that results in the display of outdated information.
Sold states
US Nationwide distribution in the states of GA, NC & TX.
Affected count
4 units
Manufactured in
High Tech Campus 36, N/A, Eindhoven, N/A, Netherlands
Products
IntelliSpace Cardiovascular, Software 8.0.0.4.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2025Don't want to check this manually?
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