FDA Device recall Z-0294-2017
Fusion Workstation
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Fusion Workstation by Merge Healthcare, citing after a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0294-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-10-28 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | AZ, CA, ID, IL, IN, MI, MN, NJ |
Product
Fusion Workstation.; Indicated for the transmission and review of radiological images.
Reason
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
Identifiers
| code_info | Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1. |
|---|
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-0294-2017%22
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