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 | In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation. |
| Product | Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data. |
| Quantity | 361 sites potentially have the affected versions |
| Distribution | US Nationwide Distribution. |
| Initiated | 2016-04-04 |
| Classified | 2017-03-13 |
| Terminated | 2019-08-05 |
| Recall number | Z-1457-2017 |
| 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-1457-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76447/
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