Merge Healthcare, Inc. recalls Merge Unity software, formerly known as DR Systems Unity PAC
Recalled Product
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Hazard / Issue
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Issued by
FDA
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