BEUDAMED
    FDA Recall Terminated

    Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.

    Recall: Z-2210-2014 · Initiated July 10, 2014

    Recall

    Recall Number
    Z-2210-2014
    Event Number
    68763
    Firm
    Medical Positioning Inc
    FEI Number
    1000118382
    Product Code
    LGX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 10, 2014
    Posted
    August 13, 2014
    Terminated
    January 3, 2017
    Address
    1717 Washington St, Kansas City, MO, 64108-1121

    Description

    Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. 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.

    Action

    Medical Positioning Inc. sent Potential Product Hazard Bulletin letter dated July 8, 2014 to affected customers, via USPS certified return receipt mail. The letter identified the affected product, problem and actions to be taken. Customers were informed a Product Support Specialist will contact them to make arrangements for a Field Service Technician to perform a test designed to identify if the table component affects the table mechanics. If the table is identified as having the affected component, the component will be replaced.

    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

    17 beds