FDA Device recall Z-2566-2018
Merge Unity software, formerly known as DR Systems Unity PACS software
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of Merge Unity software, formerly known as DR Systems Unity PACS software by Merge Healthcare, citing the software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2566-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-07 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
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.
Reason
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Identifiers
| code_info | Software versions 10.0.6 and 10.0.7. Only customers with these 2 versions AND a license for Mammo Tracking are impacted by this recall. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2566-2018%22
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