FDA Device recall Z-1142-2017
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Im…
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Im… by Merge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1142-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-09 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | 136 T1700 Capture Stations 46 T5810 Capture Stations |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1142-2017%22
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