Merge Healthcare, Inc. recalls Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading…

Recall date

March 28, 2016

Source

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

Recall number

Z-0726-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) Canada and foreign distribution

Why it was recalled

Cut lines on the image may present horizontally rather than vertically.

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 PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.