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FDASeptember 22, 2015device

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

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

The hazard

For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.

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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