Merge Healthcare, Inc. Recall 88379
Description: Merge Hemo, Software packages 10.2, 10.3, and 10.4
Merge Healthcare, Inc. Recall 88379 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2387-2021 |
| Event ID | 88379 |
| Event Description | Merge Hemo, Software packages 10.2, 10.3, and 10.4 |
| Product Type | Devices |
| Distribution | US distribution |
| Quantity | 326 units |
| Recall 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. |
| Device Classification | 20210908 |
| Device Code Info | Version 10.2, UDI (01)00842000100430(10)10.2(11)190612 Version 10.3, UDI (01)00842000100874(10)10.3(11)200330 Version 10.4, UDI (01)00842000100966(10)10.4(11)210428 |
| Center Classification Date | 20210828 |
| Recall Initiation Date | 20210723 |
| Recalling Firm | Merge Healthcare, Inc. |
| Initial Notification | |
| Similar To |