Merge Healthcare, Inc. recalls Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, an…

Recall date

April 4, 2016

Source

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

Recall number

Z-1778-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.

Why it was recalled

Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.

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 Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure