Date Initiated by Firm | September 26, 2012 |
Date Posted | April 17, 2013 |
Recall Status1 |
Terminated 3 on May 07, 2018 |
Recall Number | Z-1020-2013 |
Recall Event ID |
64734 |
Product Classification |
Unit x-ray intraoral - Product Code EAP
|
Product | DeGotzen XRay unit XGenus
Dental X-ray unit. |
Code Information |
766471 |
Recalling Firm/ Manufacturer |
DeGotzen via Roma 45 Olgiate Olona Varese Italy
|
For Additional Information Contact | Mr.Rick Rosati 800-289-6367 Ext. 390 |
Manufacturer Reason for Recall | It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
Action | DeGotzen will add new labeling or change existing labeling to correct for the 5 mentioned deficiencies. This correction of the noncompliant products must be made at no cost to the customers.
For further questions please call 800-289-6367 ext. 390. |
Quantity in Commerce | 159 units |
Distribution | US (nationwide) |
Total Product Life Cycle | TPLC Device Report |
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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.
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