Merge Unity software recall: Incorrect cancer risk calculation due to patient
Merge Healthcare recalls specific software versions that may misidentify patients with atypical hyperplasia, leading to incorrect cancer risk assessments. Affected users must verify their software version and license status.
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 two software versions (10.0.6 and 10.0.7) that may incorrectly calculate cancer risk by failing to identify patients with atypical hyperplasia. This could lead to inaccurate cancer risk assessments for patients using the software. Read more at govinfonow.com/recall/73164-merge-unity-software-recall-incorrect-cancer-risk-calculation-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/73164-merge-unity-software-recall-incorrect-cancer-risk-calculation-due-to · Updated September 18, 2026 · FDA enforcement record: FDA #Z-2566-2018
Cite this page
“Merge Unity software recall: Incorrect cancer risk calculation due to patient.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73164-merge-unity-software-recall-incorrect-cancer-risk-calculation-due-to. Based on FDA recall #Z-2566-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2566-2018%22&limit=1).
Why it’s dangerous
The software fails to correctly identify patients with atypical hyperplasia, a condition that increases cancer risk. This error causes the system to produce an incorrect Gail Risk calculation, potentially leading to inaccurate cancer risk assessments for patients.
Who’s affected
Healthcare providers using Merge Unity software versions 10.0.6 or 10.0.7 with a Mammo Tracking license are affected. Patients using this software for medical imaging may be at risk of incorrect cancer risk calculations.
How to tell if you have this one
Check if your software version is 10.0.6 or 10.0.7 and if you have a Mammo Tracking license. The software is used for medical imaging systems and is labeled as Merge Healthcare, Hartland, WI.
- Brand
Merge Healthcare- Category
Medical device
What to do — step by step
Verify Software Version
Check your software version to see if it is 10.0.6 or 10.0.7.
Confirm License Status
Ensure you have a Mammo Tracking license to be impacted by this recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Kentucky, Maine, Ohio, Oregon, Tennessee, Texas, Washington, West Virginia.
Recall timeline
FDA terminated this recall 2.8 years 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.
Similar recalls
Latest medical device recalls
Keep exploring
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-2566-2018 (August 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2566-2018 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.