FDAClass IIMarch 26, 2025

Vericis recall

VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information…

Why was Vericis recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: Software Version Numbers and UDIs 12.0.1, UDI: (01)00842000100768(10)12.0.1(11)200107; 12.0.2, UDI: (01)00842000100768(10)12.0.2(11)201117

Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information…
Recalling firm
Merge Healthcare, Inc.
Quantity
37
Distribution
US
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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