Recall Z-1091-2017 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
| Date | Mar 28, 2016 |
| Status | Terminated |
| Reason | There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC. |
| Root cause | Software design |
| Action | MERGE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to reply using the enclosed form and ensure all users of the product are provided with the notification. Customers with questions were instructed to send an email to recall@merge.com.. |
| Quantity | 242 sites potentially have the affected versions |
| 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 |