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U.S. Department of Health and Human Services

Class 2 Device Recall Owandy Radiology IMAX Touch 3D

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  Class 2 Device Recall Owandy Radiology IMAX Touch 3D see related information
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
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