Merge Unity Z3D software — Class II medical device recall Z-2551-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-08-24, distributed in CA, MT, PA, TX. The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to
| Recall number | Z-2551-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2015-07-23 |
| Classified | 2016-08-16 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2016-10-07 |
| Distributed | CA, MT, PA, TX |
| Quantity | 9 sites |
| Reason classes | software |
Product
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.
Reason for recall
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2551-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.