BEUDAMED
    FDA Enforcement Class II Terminated

    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.

    Recall: Z-2635-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2635-2014
    Event ID
    69038
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    JK Products & Services, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2014
    Initiation Date
    July 25, 2014
    Classification Date
    September 12, 2014
    Termination Date
    January 13, 2017
    Address
    1 Walter Kratz Dr, N/A, Jonesboro, AR, 72401-0609, United States

    Description

    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.

    Reason

    The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).

    Code Info

    PN 8000809705; Serial numbers 248-1298

    Distribution

    Nationwide Distribution.

    Quantity

    1948 units