FDAOctober 26, 2015device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
merge healthcaremerge
Recall history
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