Recall Z-1457-2017 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated March 28, 2016 via e-mail. If no email address was available, the letters were issued via certified mail. Non-responders were issued letters on July 11, 2016. The letter identified the affected product, problem and actions to be taken. For question send an email to recall@merge.com. |
| Quantity | 361 sites potentially have the affected versions |
| Distribution | US 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 |