Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display…

Recall date

February 5, 2016

Source

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

Recall number

Z-2363-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Worldwide Distribution -- USA and Australia.

Why it was recalled

When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.

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, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.