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 | There is a potential for duplicate container numbers to be created for patients. |
| Product | Merge LIS software. |
| Quantity | 413 sites potentially have the affected software |
| Distribution | Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas. |
| Initiated | 2015-03-05 |
| Classified | 2016-11-11 |
| Terminated | 2019-04-12 |
| Recall number | Z-0399-2017 |
| 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-0399-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75419/
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