FDA Device recall Z-0939-2019
The WinStation Retinal Imager, also known as Merge Eye Station
- FDA Device
- Class II
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class II recall of The WinStation Retinal Imager, also known as Merge Eye Station by Merge Healthcare, citing 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 all….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0939-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-20 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Merge Healthcare |
| Distribution | US |
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
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).
Identifiers
| code_info | UDI: 00842000100140. Serial Numbers: a0L3200000BVmMo, a0L3200000DyTSA, a0L3200000AiuLX, a0L3200000BUou2, a0L0e00000EPui…UDI: 00842000100140. Serial Numbers: a0L3200000BVmMo, a0L3200000DyTSA, a0L3200000AiuLX, a0L3200000BUou2, a0L0e00000EPuiz, a0L3200000BVZ7i, a0L3200000Ajd0n, a0L3200000C04Ol, a0L3200000Aj6EX, a0L32000009gkeu, a0L3200000BUOXv, a0L3200000Aj6TP, a0L3200000BTnqr, a0L3200000AjTBg, a0L32000008q1mk, a0L0e00000DzQ3a, a0L3200000B2Csy, a0L32000009hJZk, a0L32000009n0mi, a0L0e00000E0aFN, a0L3200000DyFdA, a0L0e00000EPw0a, a0L3200000C03vm, a0L3200000DyF4P, a0L3200000AjY5P, a0L32000009n1Mk, a0L3200000B1MV5, a0L0e00000EPw6s, a0L32000008qtIF, a0L3200000BVzZ6, a0L3200000BTLiZ, a0L3200000Aj6bv, a0L0e00000E0C04, a0L3200000AihSR, a0L3200000AihUh, a0L3200000BUc9x, a0L3200000BUcAH, a0L32000009hLmm, a0L3200000AivBM, a0L3200000AjYPs, a0L32000009h8o4, a0L0e00000E07hv, a0L32000008quuk, a0L3200000DyNRS, a0L3200000B19Jt, a0L3200000B0uso, a0L0e00000E0CSc, a0L3200000B09PT, a0L3200000B09PJ, a0L3200000B09Pd, a0L3200000BTlfb, a0L3200000DiqQx, a0L32000009hJrd, a0L32000009mlt9, a0L32000009md53, a0L32000009nTWm, a0L0e00000E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0939-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.