medical Class II Updated 2018-08-08

Merge Healthcare, Inc. recalls Merge Unity software, formerly known as DR Systems Unity PAC

Recalled 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 systems.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software versions 10.0.6 and 10.0.7. Only customers with these 2 versions AND a license for Mammo Tracking are impacted by this recall.
View official government recall

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