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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Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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