Reported Nov 23, 2016 · Terminated

iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.

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?

  • iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Lot codes and dates
    • Versions 3.0.1
    • 3.1
    • and 3.2
Amount recalled
60 sites potentially have the affected versions

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

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 Aug 28, 2019 · Data as of Sep 19, 6:07 PM UTC

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