BEUDAMED
    FDA Recall Open, Classified

    Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

    Recall: Z-2889-2018 · Initiated May 23, 2018

    Recall

    Recall Number
    Z-2889-2018
    Event Number
    80769
    Firm
    Ortho Kinematics, Inc
    FEI Number
    3006172536
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    May 23, 2018
    Address
    110 Wild Basin Rd, Ste 250, West Lake Hills, TX, 78746-3352

    Description

    Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

    Reason

    This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.

    Action

    Ortho Kinematics notified customers via Email and notification through web app with a notification dated December 6, 2016. The notification contained the following information: reason for correction, report information, and required action for acknowledgement.

    Distribution

    U.S. Nationwide Distribution

    Quantity

    1