Recall Z-0554-2016 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
| Date | Oct 26, 2015 |
| Status | Terminated |
| Reason | The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. |
| Root cause | Process control |
| Action | Consignees were either contacted via phone 9/2015 or in person 7/31/2015. The customer communications involved the need to upgrade the consignees software. Merge Healthcare did not script the conversations because they opted to hold one-on-one management level discussions to carefully explain the importance of moving to the Generally Available (GA) release. |
| Quantity | 2 |
| Distribution | Distributed in the states of IL, NC, and VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082421 | HEARTSUITE HEMODYNAMICS 7.10 Emageon, Inc., Dec 17, 2008 |