Merge Cardio software — Class II medical device recall Z-0730-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-12-21, distributed nationwide. Reporting feature times out after inactivity for more than an hour sending the user back to the study list, wh
| Recall number | Z-0730-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2015-10-01 |
| Classified | 2016-12-09 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2018-03-23 |
| Distributed | Nationwide (US) |
| Quantity | 116 sites |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0730-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.