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 | Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost. |
| Product | Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data |
| Quantity | 116 sites potentially have the effected versions |
| Distribution | Nationwide Distribution |
| Initiated | 2015-10-01 |
| Classified | 2016-12-09 |
| Terminated | 2018-03-23 |
| Recall number | Z-0730-2017 |
| 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-0730-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75714/
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