Merge Eye Station — Class II medical device recall Z-1142-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-02-15, distributed nationwide. Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the inte
| Recall number | Z-1142-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-12-09 |
| Classified | 2017-02-06 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2018-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB |
| Quantity | 182 capture |
| Model numbers | 136, T1700 |
Product
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
Reason for recall
Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health.
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-1142-2017. 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.