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Software issue that results in the display of outdated information.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-Device2026-06-24Philips Allura Xper imaging systems recalled for hand switch button malfunction risk
- FDA-Device2026-06-24Philips MultiDiagnost Eleva X-ray systems recalled for hand switch button malfunction risk
- FDA-Device2026-06-03Philips Allura medical imaging systems recalled for hard drive failure risk
- FDA-Device2026-06-03Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
- FDA-Device2026-05-27Philips Allura X-ray systems recalled for potential cooling unit oil leakage
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