FDA Device recall Z-2709-2016
Merge Cardio software
- FDA Device
- Class II
- terminated
- Published 2016-09-07
On 2016-09-07 the FDA classified a Class II recall of Merge Cardio software by Merge Healthcare, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2709-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-09 |
| Published | 2016-09-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Reason
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).
Identifiers
| code_info | Versions 10.1 and 10.1.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2709-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.