Merge PACS and Merge OrthoPACS — Class II medical device recall Z-3004-2026
Ongoing recall by Merge Healthcare, Inc., reported 2026-09-02, distributed nationwide. Software issue may cause measurements to be displayed inaccurately.
| Recall number | Z-3004-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2026-07-22 |
| Classified | 2026-08-21 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00842000101239 |
Product
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Reason for recall
Software issue may cause measurements to be displayed inaccurately.
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-3004-2026. 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.