Merge Healthcare, Inc. recalls Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for so…

Recall date

March 28, 2016

Source

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

Recall number

Z-0599-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide including Canada.

Why it was recalled

The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.

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. Product Usage: 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.