medical Class II Updated 2025-03-26

Merge Healthcare, Inc. recalls VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, S

Recalled Product

VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.


Hazard / Issue

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.

Issued by

FDA

Distribution: US
Lot/Code Info: Software Versions and Part Numbers: 10.0: Part Numbers: 88-00527-00, 88-00528-00, 88-00529-00, 88-00530-00, 88-00531-00, 88-00532-00, 88-00533-00, 70-00008-00; 10.1.1.1: Part Numbers: 88-01094-00; 10.1.2: Part Numbers: 88-01074-00, 88-01075-00, 88-01076-00, 88-01077-00, 88-01078-00, 88-01079-00, 88-00781-00, 88-00803-00, 88-01080-00, 70-00473-00; 10.2.0: Part Numbers: 88-01115-00, 88-01116-00, 88-01117-00, 88-01118-00, 88-01119-00, 88-01120-00, 88-01121-00, 88-01122-00, 88-01123-00, 70-00491-00, 10.2 P2: Part Numbers: 88-01203-00 10.3 P1 UDI - (01)00842000100041(10)10.3.0.2009(11)170309
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