BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2890-2018
    Event ID
    80768
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho Kinematics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 29, 2018
    Initiation Date
    August 12, 2016
    Classification Date
    August 22, 2018
    Address
    110 Wild Basin Rd Ste 250, West Lake Hills, TX, 78746-3352, United States

    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.

    Code Info

    00868579000209

    Distribution

    U.S. Nationwide Distribution

    Quantity

    1