Merge Healthcare, Inc. recalls VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrat…

Recall date

February 19, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1401-2025

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.