Merge Healthcare, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1399-2025)

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:

VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

Product Classification:

Class II

Date Initiated: February 19, 2025

Date Posted: March 26, 2025

Recall Number: Z-1399-2025

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: 11

Code Information:

Software Versions and Part Numbers: 10.0: Part Numbers: 88-00527-00, 88-00528-00, 88-00529-00, 88-00530-00, 88-00531-00, 88-00532-00, 88-00533-00, 70-00008-00; 10.1.1.1: Part Numbers: 88-01094-00; 10.1.2: Part Numbers: 88-01074-00, 88-01075-00, 88-01076-00, 88-01077-00, 88-01078-00, 88-01079-00, 88-00781-00, 88-00803-00, 88-01080-00, 70-00473-00; 10.2.0: Part Numbers: 88-01115-00, 88-01116-00, 88-01117-00, 88-01118-00, 88-01119-00, 88-01120-00, 88-01121-00, 88-01122-00, 88-01123-00, 70-00491-00, 10.2 P2: Part Numbers: 88-01203-00 10.3 P1 UDI - (01)00842000100041(10)10.3.0.2009(11)170309

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated