Date Initiated by Firm |
August 05, 2015 |
Date Posted |
November 06, 2015 |
Recall Status1 |
Terminated 3 on March 22, 2017 |
Recall Number |
Z-0129-2016 |
Recall Event ID |
71958 |
510(K)Number |
K130443
|
Product Classification |
X-ray, tomography, computed, dental - Product Code OAS
|
Product |
Owandy Radiology I -MAX Touch 3D X-ray |
Code Information |
p/n 9306251191 and 9306651191 |
Recalling Firm/ Manufacturer |
Villa Radiology Systems LLC 91 Willenbrock Rd Ste B1 Oxford CT 06478-1036
|
Manufacturer 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 2 |
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 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. |
Quantity in Commerce |
I-MAX Touch 3D- 6 installed |
Distribution |
US Distribution |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = OAS and Original Applicant = OWANDY
|