FDA Device recall Z-0129-2016
Owandy Radiology I -MAX Touch 3D X-ray
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of Owandy Radiology I -MAX Touch 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-0129-2016 |
| 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
Owandy Radiology I -MAX Touch 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 9306251191 and 9306651191 |
|---|
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-0129-2016%22
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