Merge Unity Software Recall: Incorrect Gail Risk Calculation for Atypical Hyperplasia
Merge Healthcare recalls specific versions of their Unity PACS software due to incorrect Gail Risk calculations for atypical hyperplasia. Affected users must verify their software version and Mammo Tracking license.
Lower-risk recall
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Contact the company
What happened, in plain English
Merge Healthcare is recalling specific versions of their Unity PACS software because it fails to correctly identify patients with atypical hyperplasia, leading to inaccurate Gail Risk calculations. This could result in incorrect cancer risk assessments for patients using the software. Read more at govinfonow.com/recall/73141-merge-unity-software-recall-incorrect-gail-risk-calculation-for-atypical.
Source Summary by GovInfoNow · govinfonow.com/recall/73141-merge-unity-software-recall-incorrect-gail-risk-calculation-for-atypical · Updated September 18, 2026 · FDA enforcement record: FDA #Z-3105-2017
Cite this page
“Merge Unity Software Recall: Incorrect Gail Risk Calculation for Atypical Hyperplasia.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73141-merge-unity-software-recall-incorrect-gail-risk-calculation-for-atypical. Based on FDA recall #Z-3105-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3105-2017%22&limit=1).
Why it’s dangerous
The software incorrectly calculates cancer risk for patients with atypical hyperplasia by failing to properly identify this condition. This leads to inaccurate Gail Risk assessments, which could result in missed or delayed cancer screenings.
Who’s affected
Healthcare providers using Merge Unity software versions 10.0 through 11.1.2 Patch 4 with a Mammo Tracking license are affected. Patients receiving imaging services through this software may be at risk of incorrect cancer risk evaluations.
How to tell if you have this one
Check your software version number (10.0 through 11.1.2 Patch 4) and ensure you have a Mammo Tracking license. The product label states the manufacturer as Merge Healthcare, Hartland, WI.
- Brand
Merge Healthcare- Category
Medical device
What to do — step by step
Verify Software Version
Check your software version number to confirm it is one of the affected versions listed (10.0 through 11.1.2 Patch 4).
Confirm Mammo Tracking License
Ensure you have a license for Mammo Tracking, as this is required for the recall to apply.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3105-2017 (August 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3105-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.