Recall Z-0128-2016 ยท MUH System, X-Ray, Extraoral Source, Digital
Villa Radiology Systems LLC
Villa Sistemi Rotograph EVO 3D X-ray
| Date | Nov 6, 2015 (initiated Aug 5, 2015) |
| Status | Terminated |
| 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). |
| Root cause | Other |
| Action | Villa Radiology Systems Planned Action: 1. The current users manuals have been updated and addendums to the user manuals have been developed for currently installed Rotograph Evo 3D and Imax Touch 3D. The revisions and addendums contain all information required under 21 CFR 1020.33(c), 1020.33(d), 1020.33(g), and 1020.33(j). 2. New Rotograph Evo 3D and Imax Touch 3D systems will ship with the updated user manual. 3. Addendums will be provided to all end users CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 1 |
| Quantity | Rotograph EVO 3D - 8 installed |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111152 | ROTOGRAPH EVO 3D Villa Sistemi Medicali S.P.A., Jul 22, 2011 |