Recall Z-2341-2016 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
Merge HEMO software.
| Date | Aug 4, 2016 (initiated Jul 2, 2012) |
| Status | Terminated |
| Reason | The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7 |
| Root cause | Software design |
| Action | The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response. |
| Quantity | 37 |
| Distribution | The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082421 | HEARTSUITE HEMODYNAMICS 7.10 Emageon, Inc., Dec 17, 2008 |