Merge Healthcare, Inc. recalls Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Me…

Recall date

January 30, 2016

Source

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

Recall number

Z-2379-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.

Why it was recalled

The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.

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 was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.