Company: Merge Healthcare, Inc.
Date of Enforcement Report 4/19/2017
Class lI:
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
Recall Number Z-1778-2017
REASON
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
24 sites potentially have the affected accessory
DISTRIBUTION
Nationwide and Internationally
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