Merge Cardio software — Class II medical device recall Z-2123-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-05-31, distributed in AZ, CT, FL, GA, IL, IN, LA, MI…. Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study
| Recall number | Z-2123-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-04-13 |
| Classified | 2017-05-22 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2017-07-17 |
| Distributed | AZ, CT, FL, GA, IL, IN, LA, MI, NC, NY, OH, OK, TX, VT |
| Quantity | 30 sites |
Product
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
Reason for recall
Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.
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-2123-2017. 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.