Z-1402-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 253
Product Description
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
Reason for Recall
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
Distribution Pattern
US
Code Information
Lot Code: Software versions and UDIs 12.4.1 UDI: (01)00842000101123(10)12.4.1(11)240522 12.4.2 UDI: (01)00842000101123(10)12.4.2(11)250206 12.1, UDI: (01)00842000100928(10)12.1(11)210122; 12.1.1, UDI: (01)00842000100928(10)12.1.1(11)211220; 12.2 UDI: (01)00842000100065(10)12.2.0(11)220713; 12.3, UDI: (01)00842000101109(10)12.3.0(11)221114; 12.3.1 UDI: (01)00842000101109(10)12.3.0(11)221114; 12.3.2 UDI: (01)00842000101109(10)12.3.2(11)230612; 12.3.3 UDI: (01)00842000101109(10)12.3.3(11)230913; 12.4 UDI: (01)00842000101123(10)12.4.0(11)231220; 12.4.1 UDI: (01)00842000101123(10)12.4.1(11)240522; 12.4.2 UDI: (01)00842000101123(10)12.4.2(11)250206