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Merge Healthcare, Inc. recalls Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare,
Recalled September 13, 2017 · FDA recall Z-3105-2017 · Merge Healthcare
Hazard
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. · FDA Class II
Units
98 sites have the potentially affected software
Sold at
Nationwide Distribution
Description
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
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
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →