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U.S. Department of Health and Human Services

Class 2 Device Recall Orthoralix 8500 DDE Panoramic Dental XRay System

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  Class 2 Device Recall Orthoralix 8500 DDE Panoramic Dental XRay System see related information
Date Initiated by Firm February 04, 2011
Date Posted April 22, 2011
Recall Status1 Terminated 3 on February 15, 2012
Recall Number Z-2040-2011
Recall Event ID 57888
510(K)Number K050255  
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
Product Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3.

The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.
Code Information Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3 and all serial numbers .
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		 There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obviou
FDA Determined
Cause 2		 Other
Action Gendex sent a recall letter to their accounts on February 4, 2011 via first class mail, stating that an anomaly in the Orthoralix firmware can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obvious these images cannot be used for diagnostic purposes. The letter stated that resending the image from the X-Ray system to the PC will correct the issue present in certain images sent during periods of high network traffic. Instructions were provided to download an Appendix to Orthoralix DDE User Manual that explains how to resend the images. If that does not resolve the issue, users were requested to contact Gendex Technical Support at 1-800-323-8029. Customers were asked to complete and return the enclosed Acknowledgement Form by fax to 215-997-5665 or e-mail: regulatoryaffairs@gendex.com. For questions regarding this recall call 800-323-8029.
Quantity in Commerce Total 6,835 units of all products
Distribution Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.
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 = GENDEX DENTAL SYSTEMS
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