FDA Device recall Z-0665-2017
Merge Hemo software
- FDA Device
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of Merge Hemo software by Merge Healthcare, citing the application may crash during the cath lab procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0665-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-30 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories
Reason
The application may crash during the cath lab procedure.
Identifiers
| code_info | Versions 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, and 9.40.2 with Windows 7 Operating System |
|---|
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-0665-2017%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.