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 | An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative. |
| Product | Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS 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 | 62 units |
| Distribution | US Nationwide distribution including in the states of IL, TX, OR, AZ, OH, TN, CA, UT, MO, GA, NM, OK, VA, IN, CT, and VT. |
| Initiated | 2020-05-08 |
| Classified | 2020-06-19 |
| Terminated | 2023-06-23 |
| Recall number | Z-2403-2020 |
| 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-2403-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85633/
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