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

Recall date

May 8, 2017

Source

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

Recall number

Z-2591-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.

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