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FDAApril 13, 2016device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

merge healthcaremerge

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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