Merge Healthcare, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1402-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 19, 2025

Date Posted: March 26, 2025

Recall Number: Z-1402-2025

Event ID: 96344

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.

Status: Ongoing

Product Quantity: 253

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

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated