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U.S. Department of Health and Human Services

Class 2 Device Recall Gendex eXpert DC Intraoral XRay System

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  Class 2 Device Recall Gendex eXpert DC Intraoral XRay System see related information
Date Initiated by Firm December 17, 2010
Date Posted February 15, 2011
Recall Status1 Terminated 3 on February 15, 2011
Recall Number Z-1248-2011
Recall Event ID 57485
510(K)Number K992610  
Product Classification Intraoral X-Ray System - Product Code EHD
Product Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA
Code Information Model 110-0205G1, catalog number EXPERTDC75NA; serial numbers 1987591 - 09/2010, 1987597 - 09/2010, 1987598 - 09/2010, 1987599 - 09/2010 and 1987600 - 09/2010
Recalling Firm/
Gendex Dental Systems
901 W Oakton St
Des Plaines IL 60018-1843
For Additional Information Contact Ms. Elizabeth Lazaro
Manufacturer Reason
for Recall
The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient.
FDA Determined
Cause 2
Component design/selection
Action Gendex sent a Urgent Medical Device Field Correction letter dated December 17, 2010 to the consignee, informing them that the x-ray units were installed with improper sized lag bolts and requesting that they contact Gendex Customer Service at 1-800-323-8029 to complete the field correction.
Quantity in Commerce 5 units
Distribution California
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 = EHD and Original Applicant = DENTSPLY INTL.