Merge HEMO software — Class II medical device recall Z-2341-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-08-10, distributed nationwide. The International Normalized Ratio (INR) value displayed in the study report does not match the value that is
| Recall number | Z-2341-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2012-07-02 |
| Classified | 2016-08-04 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2017-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 37 |
Product
Merge HEMO software.
Reason for recall
The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
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-2341-2016. 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.