FDA Enforcement
Class II
Ongoing
IntelliSpace Cardiovascular, Software 8.0.0.4.
Recall: Z-2543-2025
·
Reported September 17, 2025
Enforcement
- Recall Number
- Z-2543-2025
- Event ID
- 97379
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Medical Systems Nederland B.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 17, 2025
- Initiation Date
- August 8, 2025
- Classification Date
- September 9, 2025
- Address
- High Tech Campus 36, N/A, Eindhoven, N/A, N/A, Netherlands
Description
IntelliSpace Cardiovascular, Software 8.0.0.4.
Reason
Software issue that results in the display of outdated information.
Code Info
Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
Distribution
US Nationwide distribution in the states of GA, NC & TX.
Quantity
4 units