FDA Device recall Z-2341-2016
Merge HEMO software
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of Merge HEMO software by Merge Healthcare, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2341-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-02 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge HEMO software.
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
Identifiers
| code_info | Software versions 8.10, 9.10, 9.20. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2341-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.