Z-2543-2025 Class II Ongoing
FDA device recall Z-2543-2025 was initiated by Philips Medical Systems Nederland B.V. on August 8, 2025 and is designated Class II. Reason for recall: Software issue that results in the display of outdated information. The recall status is ongoing. Affected quantity: 4 units.
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Software issue that results in the display of outdated information.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.