Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software in…

Recall date

January 30, 2016

Source

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

Recall number

Z-2303-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.

Why it was recalled

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

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. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.