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Merge Healthcare, Inc. recalls Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquir
Recalled May 31, 2017 · FDA recall Z-2123-2017 · Merge Healthcare
Hazard
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. · FDA Class II
Units
30 sites have the potentially affected software versions
Sold at
Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
Description
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.
Product
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →