BEUDAMED
    FDA Recall Open, Classified

    Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

    Recall: Z-2891-2018 · Initiated March 2, 2017

    Recall

    Recall Number
    Z-2891-2018
    Event Number
    80771
    Firm
    Ortho Kinematics, Inc
    FEI Number
    3006172536
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 2, 2017
    Address
    110 Wild Basin Rd, Ste 250, West Lake Hills, TX, 78746-3352

    Description

    Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

    Reason

    Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.

    Action

    Ortho Kinematics notified customers via telephone, email, and letter. Letter dated August 23, 2017 contained the following information: reason for notification, error report information, and requested acknowledgement of receipt.

    Distribution

    U.S. Nationwide Distribution

    Quantity

    1