FDAFebruary 19, 2025device
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management 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
UPCs
00842000101123008420001009280084200010006500842000101109
Recall history
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