BEUDAMED
    FDA Enforcement Class II Terminated

    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations.

    Recall: Z-2211-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2211-2014
    Event ID
    68763
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Positioning Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2014
    Initiation Date
    July 10, 2014
    Classification Date
    August 13, 2014
    Termination Date
    January 3, 2017
    Address
    1717 Washington St, N/A, Kansas City, MO, 64108-1121, United States

    Description

    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations.

    Reason

    Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.

    Code Info

    Serial number--803976

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, GA, FL, IL, IN, KS, KY, MD, MN, MO, MS, NC, NY, OH, TN, TX, VA and WI.

    Quantity

    1 bed