BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2040-2011 · Initiated February 4, 2011

    Recall

    Recall Number
    Z-2040-2011
    Event Number
    57888
    Firm
    Gendex Dental Systems
    FEI Number
    3004115000
    Product Code
    EHD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 4, 2011
    Posted
    April 22, 2011
    Terminated
    February 15, 2012
    Address
    901 W Oakton St, Des Plaines, IL, 60018-1843

    Description

    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.

    Reason

    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

    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: [email protected]. For questions regarding this recall call 800-323-8029.

    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.

    Quantity

    Total 6,835 units of all products