Merge Eye Care Systems — Class II medical device recall Z-1681-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-04-05, distributed nationwide. The system will completely stop allowing the downloading or acquisition of new images due to incompatible soft
| Recall number | Z-1681-2017 |
|---|---|
| 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 | 2017-03-24 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2020-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,627 sites |
| Reason classes | software |
Product
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Reason for recall
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
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-1681-2017. 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.