Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System — Class II medical device recall Z-1017-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-01-18, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an
| Recall number | Z-1017-2017 |
|---|---|
| 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 | 2017-01-12 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2021-03-24 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | BE, BR, CA, CZ, DE, DK, DZ, FR, GB, GR, IL, IN, IT, KR, LU, MX, NL, PL, SG |
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). Versions: 11.6.0 and prior
Reason for recall
This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
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-1017-2017. 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.