BEUDAMED
    FDA Enforcement Class II 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 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0834-2014
    Event ID
    66742
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    September 17, 2013
    Classification Date
    January 27, 2014
    Termination Date
    June 5, 2017
    Address
    1595 Highway 33 S, New Tazewell, TN, 37825-7105, United States

    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.

    Code Info

    Lot Numbers: 31480713, 31480721, 31968743, 31971619, 31990844, 32005711, 32018491, 32037764, 32118020, 32710832, 32736223, 33053264, 33105221, 33141176, 33164204, 33164407, 33276273, 33329911

    Distribution

    Nationwide Distribution.

    Quantity

    738 units