FDA Device recall Z-0730-2017
Merge Cardio software
- FDA Device
- Class II
- terminated
- Published 2016-12-21
On 2016-12-21 the FDA classified a Class II recall of Merge Cardio software by Merge Healthcare, citing reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0730-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-01 |
| Published | 2016-12-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data
Reason
Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
Identifiers
| code_info | Versions V10.1 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-0730-2017%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.