BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2891-2018
    Event ID
    80771
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho Kinematics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 29, 2018
    Initiation Date
    March 2, 2017
    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), 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.

    Code Info

    00868579000209.

    Distribution

    U.S. Nationwide Distribution

    Quantity

    1