Villa Sistemi Rotograph EVO 3D X-ray
- Company
- Villa Radiology Systems Llc
- Recall Initiated
- August 5, 2015
- Posted
- November 6, 2015
- Terminated
- March 22, 2017
- Recall Number
- Z-0128-2016
- Quantity
- Rotograph EVO 3D - 8 installed
- Firm Location
- Oxford, CT
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).
Distribution
US Distribution
Lot / Code Info
p/n 9307251291, 9307351291, 9307651291
Root 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.