Merge Cardio software — Class II medical device recall Z-2709-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-09-07, distributed nationwide. A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorr
| Recall number | Z-2709-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-02-09 |
| Classified | 2016-09-01 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2017-08-24 |
| Distributed | Nationwide (US) |
| Quantity | 116 customers |
Product
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Reason for recall
A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
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-2709-2016. 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.