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/ Manufacturer |
Gendex Dental Systems 901 W Oakton St Des Plaines IL 60018-1843
|
For Additional Information Contact |
Ms. Elizabeth Lazaro 267-954-0365
|
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.
|