Class II — EOS Imaging
| Recalling firm | EOS imaging |
|---|---|
| Registered facility | EOS imaging (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation |
| Product | steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images. |
| Quantity | 36 units |
| Distribution | USA Nationwide Distribution |
| Initiated | 2013-11-29 |
| Classified | 2013-12-26 |
| Terminated | 2015-01-13 |
| Recall number | Z-0580-2014 |
| 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 — EOS Imaging (Z-0580-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66980/
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