DR Systems Unity PACS software — Class II medical device recall Z-1426-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-03-15, distributed in CA, MT, PA, TX. Reports were missing demographic header information when they were faxed to referring physicians.
| Recall number | Z-1426-2017 |
|---|---|
| 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 | 2017-03-09 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2017-03-17 |
| Distributed | CA, MT, PA, TX |
| Quantity | 9 sites |
Product
DR Systems Unity PACS software, now known as Merge Unity PACS
Reason for recall
Reports were missing demographic header information when they were faxed to referring physicians.
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-1426-2017. 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.