Class II — Merge Healthcare, Inc.
| Recalling firm | Merge Healthcare |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 182 capture stations |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of : CA, CO, CT, FL, HI, IL, IN, LA, MD, MA,M I, MN, MS. MK. NY, NC,ND, OH, OK, OR, PA, RI, TN, VA, WA and WV., and the countries of Canada and United Kingdom. |
| Initiated | 2016-12-09 |
| Classified | 2017-02-06 |
| Terminated | 2018-06-19 |
| Recall number | Z-1142-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merge Healthcare, Inc. (Z-1142-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75149/
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