BEUDAMED
    FDA Recall Terminated

    Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.

    Recall: Z-0834-2014 · Initiated September 17, 2013

    Recall

    Recall Number
    Z-0834-2014
    Event Number
    66742
    Firm
    DeRoyal Industries Inc
    FEI Number
    3003040625
    Product Code
    ILO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 17, 2013
    Posted
    January 27, 2014
    Terminated
    June 5, 2017
    Address
    1595 Highway 33 S, New Tazewell, TN, 37825-7105

    Description

    Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.

    Reason

    The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.

    Action

    DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.

    Distribution

    Nationwide Distribution.

    Quantity

    738 units