FDAFebruary 19, 2025device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
merge healthcaremerge
Recall history
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