Cl II Merge Unity software

Company: Merge Healthcare, Inc.
Date of Enforcement Report 9/13/2017
Class lI:

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
Recall Number Z-3105-2017

REASON
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 8/14/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
98 sites

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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