Merge Hemo software — Class II medical device recall Z-0665-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-12-07, distributed nationwide. The application may crash during the cath lab procedure.
| Recall number | Z-0665-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2014-04-30 |
| Classified | 2016-11-28 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2019-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 192 sites |
Product
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories
Reason for recall
The application may crash during the cath lab procedure.
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-0665-2017. 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.