FDA-Device2016-01-06Class II
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Merge Healthcare, Inc.
Hazard
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Sold states
Distributed in the states of IL, NC, and VT.
Affected count
2
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) 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-0554-2016Don't want to check this manually?
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