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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