FDA Device recall Z-1778-2017
Merge Hemo software
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Merge Hemo software by Merge Healthcare, citing use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1778-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-04 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Reason
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Identifiers
| code_info | Versions 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0. |
|---|
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-1778-2017%22
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