Recall Z-0665-2017 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
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
| Date | Apr 30, 2014 |
| Status | Terminated |
| Reason | The application may crash during the cath lab procedure. |
| Root cause | Software design |
| Action | Merge sent an Important Alert letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact Merge Support at 866-261-5761 or support@merge.com. For questions regarding this recall call 877-741-5369. |
| Quantity | 192 sites potentially have the affected software |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082421 | HEARTSUITE HEMODYNAMICS 7.10 Emageon, Inc., Dec 17, 2008 |