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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 Recall
Generator, HighVoltage , X Ray Diagnostic
see related information
Date Posted April 17, 2013
Recall Status1 Open
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
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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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