Merge Healthcare, Inc. recalls Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare,…

Recall date

August 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2566-2018

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.

Why it was recalled

The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

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

What was recalled

Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.