Fusion Workstation — Class II medical device recall Z-0294-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-10-26, distributed in AZ, CA, ID, IL, IN, MI, MN, NJ. After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect value
| Recall number | Z-0294-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2011-10-28 |
| Classified | 2016-10-20 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2016-12-14 |
| Distributed | AZ, CA, ID, IL, IN, MI, MN, NJ |
| Quantity | 13 sites |
Product
Fusion Workstation.; Indicated for the transmission and review of radiological images.
Reason for recall
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0294-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.