Merge Unity software, formerly known as DR Systems Unity… recallZ-3105-2017 · Merge Healthcare, Inc. · initiated Aug 14, 2017
Class II Terminated All recalls posted in August 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
FDA root cause category: Process design
What the company is doing
MERGE sent a Medical Device Recall letter dated August 11, 2017, to all affected customers. Customers were advised to discontinue using the affected product and to reply using the enclosed form. Customers with questions were instructed to send an email to [email protected]. For questions regarding this recall call 262-912-3514.
Recall details
- Recall number
- Z-3105-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 14, 2017
- Posted by the FDA
- Aug 18, 2017
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 98 sites have the potentially affected software
- Product code
- LLZ
- FDA submissions
- K041935, K143318
- Distribution
- Nationwide Distribution
Product description
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
Code information (models, lots, serial numbers)
Software versions 10.0, 10.0.1, 10.0.2, 10.0.3, 10.0.4, 10.0.5, 11.0, 11.0.1, 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1, 11.1.1.1, 11.1.1 Patch 2, 11.1.1 Patch 3, 11.1.2, 11.1.2 Patch 1, 11.1.2 Patch 2, 11.1.2 Patch 3, and 11.1.2 Patch 4. Only customers with one of the above listed software versions AND a license for Mammo Tracking are impacted by this recall.
Other devices under the same FDA submission
4 devices cleared under K041935, K143318 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Merge Unity PACS 11.1.2Merge Healthcare Solutions Inc. · System, Image Processing, Radiological18 reports
- Merge Unity PACS 12.0Merge Healthcare Solutions Inc. · System, Image Processing, Radiological11 reports
- Merge Unity Pacs 11.0Merge Healthcare Solutions Inc. · System, Image Processing, Radiological6 reports
- Merge Unity PACS 11.2Merge Healthcare Solutions Inc. · System, Image Processing, Radiological4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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