The WinStation Retinal Imager — Class II medical device recall Z-0939-2019
Terminated recall by Merge Healthcare, Inc., reported 2019-03-06, distributed nationwide. Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowabl
| Recall number | Z-0939-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2019-02-25 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2023-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CZ, DE, DK, DZ, GB, IL, NL |
| Quantity | 1,252 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00842000100140 |
| Serial numbers | A0L0E00000DKUPK, A0L0E00000DKUPO, A0L0E00000DKUT3, A0L0E00000DKUTX, A0L0E00000DKYL1, A0L0E00000DKYME, A0L0E00000DKYRT, A0L0E00000DKYTE, A0L0E00000DKYYN, A0L0E00000DKZ05, A0L0E00000DKZ1H, A0L0E00000DKZ2F, A0L0E00000DKZ4U, A0L0E00000DKZ6M, A0L0E00000DKZ6R, A0L0E00000DKZ70, A0L0E00000DL0BC, A0L0E00000DL0BH, A0L0E00000DL0CX, A0L0E00000DL0DN, A0L0E00000DL0GU, A0L0E00000DL0HP, A0L0E00000DL0HU, A0L0E00000DL0HZ, A0L0E00000DL0I9 and 475 more |
Product
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.
Reason for recall
Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground).
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-0939-2019. 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.