FDA Device recall Z-0128-2016
Villa Sistemi Rotograph EVO 3D X-ray
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of Villa Sistemi Rotograph EVO 3D X-ray by Villa Radiology Systems, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0128-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-05 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Villa Radiology Systems |
| Distribution | n/a |
Product
Villa Sistemi Rotograph EVO 3D X-ray
Reason
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).
Identifiers
| code_info | p/n 9307251291, 9307351291, 9307651291 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0128-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.