Merge Healthcare, Inc. recalls DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and i…

Recall date

April 8, 2016

Source

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

Recall number

Z-1385-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.

Why it was recalled

The software is not adding the correct tomo image.

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. Product Usage: Merge Unity PACS 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.