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

Recalled April 19, 2017 · FDA recall Z-1778-2017 · Merge Healthcare

Hazard

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

Units

24 sites potentially have the affected versions

Sold at

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

Description

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

Product

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

Manufacturer(s)

Merge Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →