Recall Z-2387-2021 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
Merge Hemo, Software packages 10.2, 10.3, and 10.4
| Date | Jul 23, 2021 |
| Status | Terminated |
| Reason | The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface. |
| Root cause | Under Investigation by firm |
| Action | The firm issued an Urgent Field Safety Notice by email on 07/23/2021. The letter explained the issue and provided a workaround for the safe, continued use of the instrument until a software correction can be made. |
| Quantity | 326 units |
| Distribution | US distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152864 | Merge Hemo Merge Healthcare Incorporated, Apr 7, 2016 |