Company: Merge Healthcare, Inc.
Date of Enforcement Report 5/31/2017
Class lI:
PRODUCT
Merge Cardio software
Recall Number Z-2123-2017
REASON
Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother’s MRN, resulting in the wrong fetal measurements getting referenced.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/13/2016. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
30 sites potentially have the affected versions
DISTRIBUTION
Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
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