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 patient name in the Halo title bar and the thumbnails do not match the name on displayed images. |
| Product | Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI. |
| Quantity | 93 sites have the affected version |
| Distribution | The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution. |
| Initiated | 2016-01-30 |
| Classified | 2016-08-10 |
| Terminated | 2020-10-05 |
| Recall number | Z-2379-2016 |
| 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-2379-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74773/
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