Reported Jan 11, 2017 · Terminated

DR Systems Unity PACS software, now known as Merge Unity PACS software.

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?

  • DR Systems Unity PACS software, now known as Merge Unity PACS software.
Lot codes and dates
  • Version 11.0
Amount recalled
9 sites potentially have the effected software

Where it was sold

Why it was recalled

The software fails to associate to the correct MG image if there are two images for the same view.

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 Apr 23, 2021 · Data as of Sep 19, 5:32 PM UTC

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