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Merge Healthcare, Inc. recalls VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated ca
Recalled March 26, 2025 · FDA recall Z-1398-2025 · Merge Healthcare
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. · FDA Class II
Units
2
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US
Description
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.
Product
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.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →