FDA-Device2017-09-13Class II
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
Merge Healthcare, Inc.
Hazard
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Sold states
Nationwide Distribution
Affected count
98 sites have the potentially affected software
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3105-2017Don't want to check this manually?
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