FDA-Device2025-03-26Class II
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.
Merge Healthcare, Inc.
Hazard
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.
Sold states
US
Affected count
2
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1398-2025Don't want to check this manually?
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