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 | When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient. |
| Product | Merge RadSuite software. Radiological image processing system. |
| Quantity | 10 sites have the affected software that is configured with the specific conditions listed in Code Information |
| Distribution | Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX. |
| Initiated | 2015-04-09 |
| Classified | 2016-09-02 |
| Terminated | 2017-08-24 |
| Recall number | Z-2715-2016 |
| 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-2715-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74853/
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