Z-2543-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2025
- Initiation Date
- August 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
IntelliSpace Cardiovascular, Software 8.0.0.4.
Reason for Recall
Software issue that results in the display of outdated information.
Distribution Pattern
US Nationwide distribution in the states of GA, NC & TX.
Code Information
Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.