Merge Cardio software — Class II medical device recall Z-1403-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-03-15, distributed nationwide. When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing t
| Recall number | Z-1403-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-04-04 |
| Classified | 2017-03-03 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2019-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 110 sites |
Product
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
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-1403-2017. 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.