FDA-Device2018-08-08Class 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 to CA, KY, ME, OH, OR, TN, TX, WA, WV.
Affected count
11 sites have 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-2566-2018Don't want to check this manually?
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