VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERI...
FDA Recall #Z-1398-2025 — Class II — February 19, 2025
Product Description
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; 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.
Recalling Firm
Merge Healthcare, Inc. — Hartland, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2
Distribution
US
Code Information
The following versions were introduced prior to the implementation of UDI. Version Numbers: 9.0.6, 9.0.8, Part Numbers: 88-00061-00, 88-00062-00, 88-00063-00, 88-00054-00, 88-00064-00,
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated