Merge Healthcare, Inc. recalls Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management sys…

Recall date

July 23, 2015

Source

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

Recall number

Z-2551-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US Distribution to states of: CA, PA, TX, and MT.

Why it was recalled

The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.

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 Z3D software. Merge Unity PACS (formerly DR Systems 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.