DR Systems Unity PACS software — Class II medical device recall Z-1385-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-03-08, distributed nationwide. The software is not adding the correct tomo image.
| Recall number | Z-1385-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-04-08 |
| Classified | 2017-03-01 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2017-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 28 sites |
| Reason classes | software |
Product
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity 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 not adding the correct tomo image.
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-1385-2017. 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.