Reported Sep 28, 2016 · Terminated

Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a…

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?

  • Merge Cardio software
  • Product UsageMerge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system
Lot codes and dates
  • Version 10.1
Amount recalled
42 sites potentially have the affected version

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Patient information in the header is only found on the first page of the report and not on the subsequent pages.

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

Notice updated Dec 15, 2017 · Data as of Sep 19, 6:00 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.