BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated January 11, 2017

    Recall

    Recall Number
    Z-2882-2018
    Event Number
    80680
    Firm
    Ortho Kinematics, Inc
    FEI Number
    3006172536
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    January 11, 2017
    Address
    110 Wild Basin Rd, Ste 250, West Lake Hills, TX, 78746-3352

    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.

    Action

    Ortho Kinematics Inc sent notification to customers on 1/11/2017 via Letter and electronic notification through web app. The company deployed a software upgrade (VMA version 2.3.253) on January 11, 2017.

    Distribution

    US Nationwide Distribution

    Quantity

    1