FDA recall Z-2543-2025
Philips Medical Systems Nederland B.V. · Class II · device
Product
IntelliSpace Cardiovascular, Software 8.0.0.4.
Reason for recall
Software issue that results in the display of outdated information.
Distribution
US Nationwide distribution in the states of GA, NC & TX.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-08-08
- Report date
- 2025-09-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Eindhoven, N/A, Netherlands
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2025