Reported Mar 26, 2025 · Ongoing
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated…
Merge Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- VERICIS, Merge Cardio
- Model/Catalog NumberVersion 9.x
- Software Version9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system
- Lot codes and dates
- The following versions were introduced prior to the implementation of UDI
- Version Numbers
9.0.69.0.8
- Part Numbers
88-00061-0088-00062-0088-00063-0088-00054-0088-00064-00
- Amount recalled
- 2
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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