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 | The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. |
| Product | Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). |
| Quantity | 1,627 sites potentially have the affected software |
| Distribution | Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution. |
| Initiated | 2016-04-04 |
| Classified | 2017-03-24 |
| Terminated | 2020-06-22 |
| Recall number | Z-1681-2017 |
| 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-1681-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76309/
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