FDA-Device2017-04-19Class II
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
Merge Healthcare, Inc.
Hazard
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Sold states
Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
Affected count
24 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1778-2017Don't want to check this manually?
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