Recall Z-0128-2016
Villa Radiology Systems LLC · initiated August 5, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Villa Sistemi Rotograph EVO 3D X-ray
Codes / lots: p/n 9307251291, 9307351291, 9307651291
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).
FDA-determined cause: Other
Action taken
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 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22.
Details
- Recall number
- Z-0128-2016
- Initiated
- August 5, 2015
- Posted by FDA
- November 6, 2015
- Terminated
- March 22, 2017
- Product code
- MUH – System, X-Ray, Extraoral Source, Digital
- Quantity
- Rotograph EVO 3D - 8 installed
- Distribution
- US Distribution
- Recalling firm
- Villa Radiology Systems LLC, Oxford, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0129-2016 Class II | Owandy Radiology I -MAX Touch 3D X-rayIt has been discovered that due to lack of information accompanying documents the product fails to comply… | 08/05/2015Terminated |