Drug recall
Owandy Radiology I -MAX Touch 3D X-ray
FDA recall event 71958 · Class II · Villa Radiology Systems LLC
Key facts
| Event ID | 71958 |
|---|---|
| Recall numbers | Z-0128-2016, Z-0129-2016 |
| Recalling firm | Villa Radiology Systems LLC |
| Product type | Devices |
| Products | Owandy Radiology I -MAX Touch 3D X-ray, Villa Sistemi Rotograph EVO 3D X-ray |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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). |
| Initiation date | Aug 5, 2015 |
| Report date | Nov 18, 2015 |
| Termination date | Mar 22, 2017 |
| City | Oxford |
| State | CT |
| Country | United States |
| FEI number | 3009803386 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: