Company: Merge Healthcare, Inc.
Date of Enforcement Report 11/23/2016
Class lI:
PRODUCT
MergeMerge LIS software
Recall Number Z-0399-2017
REASON
There is a potential for duplicate container numbers to be created for patients..
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 11/11/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
413 sites potentially have the affected software
DISTRIBUTION
Nationwide, the Virgin Islands and the Bahamas
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