Company: Merge Healthcare, Inc.
Date of Enforcement Report 2/1/2017
Class lI:
PRODUCT
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Recall Number Z-1091-2017
REASON
There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 3/28/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
242 sites
DISTRIBUTION
Nationwide
___________________________________
