Merge Cardio with software version 10 — Class II medical device recall Z-0555-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-01-06, distributed in IL, NC, VT. The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the
| Recall number | Z-0555-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2015-10-26 |
| Classified | 2015-12-28 |
| Reported by FDA | 2016-01-06 |
| Terminated | 2016-07-22 |
| Distributed | IL, NC, VT |
| Quantity | 1 |
| Reason classes | software |
Product
Merge Cardio with software version 10.1 LA.
Reason for recall
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
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-0555-2016. 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.