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.
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2566-2018