Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/10/2016
Class lI:
PRODUCT
Merge HEMO software
Recall Number Z-2341-2016
REASON
The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc. Hartland, WI on 7/2/2012 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
37
DISTRIBUTION
Nationwide
___________________________________
