Merge Eye Station and Merge Eye Care PACS — Class II medical device recall Z-1828-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-04-26, distributed nationwide. During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly
| Recall number | Z-1828-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-04-04 |
| Classified | 2017-04-15 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2020-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,627 sites |
Product
Merge Eye Station and Merge Eye Care PACS.
Reason for recall
During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.
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-1828-2017. 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.