Merge Healthcare, Inc. recalls Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.

Recall date

April 4, 2016

Source

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

Recall number

Z-1403-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.

Why it was recalled

When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.

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 Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.