Merge PACS software — Class II medical device recall Z-2379-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-08-17, distributed nationwide. The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
| Recall number | Z-2379-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-01-30 |
| Classified | 2016-08-10 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, GB |
| Quantity | 93 sites |
Product
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Reason for recall
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
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-2379-2016. 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.