Villa Sistemi Rotograph EVO 3D X-ray — Class II medical device recall Z-0128-2016
Terminated recall by Villa Radiology Systems LLC, reported 2015-11-18. It has been discovered that due to lack of information accompanying documents the product fails to comply with
| Recall number | Z-0128-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Villa Radiology Systems LLC, Oxford, CT, United States |
| Recall initiated | 2015-08-05 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2017-03-22 |
Product
Villa Sistemi Rotograph EVO 3D X-ray
Reason for recall
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
Machine access
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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.