Class II — Merge Healthcare, Inc.
| Recalling firm | Merge Healthcare |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values. |
| Product | Fusion Workstation.; Indicated for the transmission and review of radiological images. |
| Quantity | 13 sites potentially hae the affected version |
| Distribution | Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ. |
| Initiated | 2011-10-28 |
| Classified | 2016-10-20 |
| Terminated | 2016-12-14 |
| Recall number | Z-0294-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merge Healthcare, Inc. (Z-0294-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75425/
Alerts for Merge Healthcare
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.