FDA Device recall Z-2123-2017
Merge Cardio software
- FDA Device
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of Merge Cardio software by Merge Healthcare, citing 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 measuremen….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2123-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-13 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | AZ, CT, FL, GA, IL, IN, LA, MI, NC, NY, OH, OK, TX, VT |
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
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.
Identifiers
| code_info | Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Merge Healthcare
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-09-02 · Merge Healthcare - Merge PACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCS…
FDA Device · Class II · 2025-09-10 · Merge Healthcare - Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2123-2017%22
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