Device product
IntelliSpace Cardiovascular, Software 8.0.0.4.
Z-2543-2025
Product summary
- Event
- Event 97379
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2543-2025
Official wording
Reason: Software issue that results in the display of outdated information.
Code information: Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
Distribution pattern: US Nationwide distribution in the states of GA, NC & TX.
Derived failure modes
-
Device software or design
Software issue