FDA-Device2017-05-31Class II
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.
Merge Healthcare, Inc.
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.
Sold states
Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
Affected count
30 sites have the potentially affected software versions
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2123-2017Don't want to check this manually?
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