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U.S. Department of Health and Human Services

Class 2 Device Recall Generator, HighVoltage , X Ray Diagnostic

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  Class 2 Device Recall Generator, HighVoltage , X Ray Diagnostic see related information
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
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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