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 | System locks up which may result in potential patient injury or delay in diagnosis or treatment. |
| Product | Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare. |
| Quantity | 78 sites potentially have the affected accessory |
| Distribution | Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution. |
| Initiated | 2016-04-04 |
| Classified | 2017-03-20 |
| Terminated | 2020-06-15 |
| Recall number | Z-1498-2017 |
| 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-1498-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76312/
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