FDA-Device2025-09-17Class II
IntelliSpace Cardiovascular, Software 8.0.0.4.
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Software issue that results in the display of outdated information.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-2543-2025More Philips Medical Systems Nederland B.V. recalls
- FDA-Device2026-06-03Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
- FDA-Device2026-06-03Philips Allura medical imaging systems recalled for hard drive failure risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for cooling hose degradation risk
- FDA-Device2026-05-27Philips Integris-Allura X-ray systems recalled for cooling unit oil leakage risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for impaired table movement due to control wear
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