BEUDAMED
    FDA Recall Terminated

    CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024

    Recall: Z-0712-2008 · Initiated October 29, 2007

    Recall

    Recall Number
    Z-0712-2008
    Event Number
    45503
    Firm
    Neuro-Fitness LLC
    FEI Number
    3005026995
    Product Code
    JXK
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    October 29, 2007
    Posted
    April 8, 2008
    Terminated
    September 21, 2011
    Address
    33631 # 2, Redmond-Fall City Rd. Fall City, WA, 98024

    Description

    CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024

    Reason

    No FDA clearance for the .35Hz/.45Hz frequency option on device.

    Action

    Consignees were notified of this recall by an Urgent Device Recall Letter sent via U.S. First Class mail on 10/29/07. The letter instructs users to contact the recalling firm to make arrangements to return the device. The letter also instructs users to return an enclosed response card. Consignees who do not respond will receive a follow-up telephone call two weeks after initial mailing of recall notice. For more information, contact firm at 1-866-937-4237.

    Distribution

    Worldwide Distribution

    Quantity

    3,000 units