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 | If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient). |
| Product | Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information 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 | 198 sites potentially have the effected versions |
| Distribution | Nationwide Distribution |
| Initiated | 2016-03-28 |
| Classified | 2016-12-09 |
| Terminated | 2020-03-20 |
| Recall number | Z-0729-2017 |
| 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-0729-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75825/
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