Merge: Merge Cardio software Cl II

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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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.