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 software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up. |
| Product | CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI. |
| Quantity | 844 sites potentially have the affected versions |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made. |
| Initiated | 2016-01-30 |
| Classified | 2016-10-19 |
| Terminated | 2020-10-05 |
| Recall number | Z-0137-2017 |
| 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-0137-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75239/
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