Merge Hemo software — Class II medical device recall Z-1091-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-02-01, distributed nationwide. There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does
| Recall number | Z-1091-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-03-28 |
| Classified | 2017-01-24 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2019-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 242 sites |
Product
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Reason for recall
There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
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-1091-2017. 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.