Merge Eye Station Import Utility — Class II medical device recall Z-1246-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-03-01, distributed nationwide. Eye Station images were not importing properly and were imported under "unknown" due to an issue when validati
| Recall number | Z-1246-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-03-28 |
| Classified | 2017-02-23 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2020-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,627 sites |
Product
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Reason for recall
Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)
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-1246-2017. 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.