BEUDAMED
    FDA Recall Open, Classified

    Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

    Recall: Z-2890-2018 · Initiated August 12, 2016

    Recall

    Recall Number
    Z-2890-2018
    Event Number
    80768
    Firm
    Ortho Kinematics, Inc
    FEI Number
    3006172536
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    August 12, 2016
    Address
    110 Wild Basin Rd, Ste 250, West Lake Hills, TX, 78746-3352

    Description

    Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

    Reason

    Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.

    Action

    Ortho Kinematics, Inc. notified customers via email dated August 19, 2016, Notice of Correction to VMA Results. The notification included the following information: reason for notice of correction, error information, and required action of acknowledgement.

    Distribution

    U.S. Nationwide Distribution

    Quantity

    1