Class 2 Device Recall Generator, HighVoltage , X Ray Diagnostic

• Date Initiated by Firm: September 26, 2012
• Date Posted: April 17, 2013
• Recall Status: Terminated 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
• FEI Number: 3002994636
• 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: 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.