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U.S. Department of Health and Human Services

Class 2 Device Recall Gendex CB500 3D Dental Imaging System

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 Class 2 Device Recall Gendex CB500 3D Dental Imaging Systemsee related information
Date Initiated by FirmJanuary 08, 2009
Date PostedMay 22, 2009
Recall Status1 Terminated 3 on June 04, 2009
Recall NumberZ-1265-2009
Recall Event ID 51424
510(K)NumberK061284 
Product Classification System,x-ray,extraoral source,digital - Product Code MUH
ProductGendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.
Code Information Model number: G1-15-1-0; Serial Numbers: NU010261, NU010340, NU010224, NU010286, NU010265, NU010267, NU010282, NU010283, NU010284, NU010287, NU010288, NU010289, NU010292, NU010293, NU010294, NU010299, NU010303, NU010310, NU010315, NU010316, NU010317, NU010326, NU010290, and NU010291.
FEI Number 3021551875
Recalling Firm/
Manufacturer		 Imaging Sciences International, LLC
1910 North Penn Rd
Hatfield PA 19440-1960
For Additional Information ContactAndrew Kochanasz
800-205-3570 Ext. 299
Manufacturer Reason
for Recall		faulty calibration
FDA Determined
Cause 2		Nonconforming Material/Component
ActionImaging Sciences International issued a letter to Customers dated January 7, 2009 informing them of the affected device. Users were advised to discontinue use of the device until they are contacted by a service representative and a certified re-calibration of the device is performed. Users were also asked to return a completed "Acknowledgement Form" by fax to the firm at 1-215-997-5665. Additional questions can be made to Imaging Sciences International by calling 1-800-205-3570 Extension 299.
Quantity in Commerce24 units
DistributionWorldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUH
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