Company: Merge Healthcare, Inc.
Date of Enforcement Report 4/19/2017
Class lI:
PRODUCT
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Recall Number Z-1762-2017
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
333 sites potentially have the affected accessory
DISTRIBUTION
Distribution was made nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government/military distribution was also made.
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