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.
Enforcement
- Recall Number
- Z-1399-2025
- Event ID
- 96344
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Merge Healthcare, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 26, 2025
- Initiation Date
- February 19, 2025
- Classification Date
- March 20, 2025
- Address
- 900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States
Description
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.
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.
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
US
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