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 | 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. |
| Product | Merge Eye Station and Merge Eye Care PACS. |
| Quantity | 1,627 sites potentially have the affected versions |
| Distribution | Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution. |
| Initiated | 2016-04-04 |
| Classified | 2017-04-15 |
| Terminated | 2020-06-22 |
| Recall number | Z-1828-2017 |
| 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-1828-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76844/
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