Merge Eye Station Import Utility — Class II medical device recall Z-1498-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-03-29, distributed nationwide. System locks up which may result in potential patient injury or delay in diagnosis or treatment.
| Recall number | Z-1498-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-04-04 |
| Classified | 2017-03-20 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2020-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 78 sites |
Product
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Reason for recall
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
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-1498-2017. 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.