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 | Multiple studies were missing at a customer location that never made it to the archive before watermarking |
| Product | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. |
| Quantity | 45 sites potentially have the affected versions |
| Distribution | Distribution was nationwide to medical facilities. Government distribution was made to LA and OK. |
| Initiated | 2013-05-06 |
| Classified | 2016-09-14 |
| Terminated | 2019-07-26 |
| Recall number | Z-2796-2016 |
| 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-2796-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74815/
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