Merge Healthcare, Inc. recalls Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, st…

Recall date

April 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2123-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.