Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems Recalled by Merge Healthcare, Inc. Due to The software is unable to accurately determine the...
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 Z3D software. Merge Unity PACS (formerly DR Systems PACS) 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: 9 sites potentially have the affected version
Why Was This Recalled?
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Where Was This Sold?
This product was distributed to 4 states: CA, MT, PA, TX
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