FDA Device recall Z-2551-2016
Merge Unity Z3D software
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of Merge Unity Z3D software by Merge Healthcare, citing the software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2551-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-23 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | CA, MT, PA, TX |
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
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Identifiers
| code_info | Version 11.0 |
|---|
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-2551-2016%22
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