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U.S. Department of Health and Human Services

Class 2 Device Recall eXpertDC intraoral xray

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  Class 2 Device Recall eXpertDC intraoral xray see related information
Date Initiated by Firm August 12, 2014
Date Posted October 02, 2014
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-0009-2015
Recall Event ID 69064
510(K)Number K992610  
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
Product eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly
w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm
& Tubehead, 765DC

Product Usage: intraoral x-ray
Code Information Models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC; with multiple part numbers and serial numbers: see distribution list for these details.
Recalling Firm/
Manufacturer		 Gendex Corp
2800 Crystal Dr
Hatfield PA 19440-1944
For Additional Information Contact Customer Support
267-954-1463
Manufacturer Reason
for Recall		 Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Gendex sent a Recall Notification Letter, dated August 12, 2014 and a second Communication Notification letter on September 22, 2014 to all affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Gendex Customer Service at 1-800-323-8029.
Quantity in Commerce 651
Distribution Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.
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.
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