FDA recall Z-1399-2025

Merge Healthcare, Inc. · Class II · device

Product

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.

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

US

Key facts

Status
Ongoing
Initiation date
2025-02-19
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hartland, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1399-2025