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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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.