Merge OrthoPACS software — Class II medical device recall Z-2601-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-06-28, distributed nationwide. Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destina
| Recall number | Z-2601-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2017-05-24 |
| Classified | 2017-06-16 |
| Reported by FDA | 2017-06-28 |
| Terminated | 2019-10-15 |
| Distributed | Nationwide (US) |
| Quantity | 160 sites |
| Reason classes | device malfunction |
Product
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
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-2601-2017. 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.