Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merge Unity software Recalled by Merge Healthcare, Inc. Due to The software is not identifying the patient as...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merge Healthcare, Inc. directly.
Affected Products
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
Quantity: 98 sites have the potentially affected software
Why Was This Recalled?
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Merge Healthcare, Inc.
Merge Healthcare, Inc. has 93 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report