BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2889-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2889-2018
    Event ID
    80769
    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
    May 23, 2018
    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), 2.3.250. 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.

    Code Info

    00868579000209

    Distribution

    U.S. Nationwide Distribution

    Quantity

    1