BEUDAMED
    FDA Enforcement Class II Ongoing

    Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.

    Recall: Z-2882-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2882-2018
    Event ID
    80680
    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
    January 11, 2017
    Classification Date
    August 21, 2018
    Address
    110 Wild Basin Rd Ste 250, West Lake Hills, TX, 78746-3352, United States

    Description

    Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.

    Reason

    Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.

    Code Info

    UDI: 00868579000209

    Distribution

    US Nationwide Distribution

    Quantity

    1