FDAHealthAugust 8, 2025
Philips Medical Systems Nederland B.V. — IntelliSpace Cardiovascular, Software 8.0.0.4.
⚠️ Software issue that results in the display of outdated information.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 8, 2025
US Nationwide distribution in the states of GA, NC & TX.
What's affected?
- Product
- IntelliSpace Cardiovascular, Software 8.0.0.4.
- Lot code
- Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
Additional details
Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4 units.
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