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FDAFebruary 9, 2016device

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

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

The hazard

A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).

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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