BEUDAMED
    FDA Enforcement Class II Terminated

    Cervical Extension Machine for Physical Therapy

    Recall: Z-0936-2015 · Reported January 14, 2015

    Enforcement

    Recall Number
    Z-0936-2015
    Event ID
    69422
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MedX Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2015
    Initiation Date
    December 3, 2013
    Classification Date
    January 7, 2015
    Termination Date
    September 29, 2016
    Address
    839 Nw 25th Ave, N/A, Ocala, FL, 34475-5789, United States

    Description

    Cervical Extension Machine for Physical Therapy

    Reason

    Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.

    Code Info

    Serial Numbers: 02511166, 02511167, 02511171, 02511170.

    Distribution

    Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.

    Quantity

    4