steroEOS Workstation with software versions: 1 — Class II medical device recall Z-0580-2014
Terminated recall by EOS Imaging, reported 2014-01-01, distributed nationwide. Error copying information to the clinical file and to the report when two 3D models are opened simultaneously
| Recall number | Z-0580-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EOS Imaging, Paris France, N/A, France |
| Recall initiated | 2013-11-29 |
| Classified | 2013-12-26 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2015-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 36 units |
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.
Reason for recall
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
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-0580-2014. 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.