Medical device recalls Moderate risk

Merge Healthcare, Inc. recalls DR Systems Unity PACS software, now known as Merge Unity PACS software.

Recall date
October 15, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0939-2017
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
Distribution was made to medical facilities located in MT, CA, PA, and TX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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