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
    • 9.0.6
    • 9.0.8
  • Part Numbers
    • 88-00061-00
    • 88-00062-00
    • 88-00063-00
    • 88-00054-00
    • 88-00064-00
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.