BEUDAMED
    FDA Recall Terminated

    Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)

    Recall: Z-0218-2007 · Initiated August 23, 2006

    Recall

    Recall Number
    Z-0218-2007
    Event Number
    36394
    Firm
    Nihon Kohden America Inc
    FEI Number
    2080783
    Product Code
    GWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 23, 2006
    Posted
    November 28, 2006
    Terminated
    May 23, 2008
    Address
    90 Icon, Foothill Ranch, CA, 92610-3000

    Description

    Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)

    Reason

    When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time.

    Action

    All customers will be called by phone, then faxed the Product Notification starting 09/01/2006 Customers were instructed to indicate the serial numbers on each of your MS-210BK stimulators and fax the MS-210BK PRODUCT RECALLREPLACEMENT letter back to Nihon Kohden at: 949-580-15550 or email to [email protected]. Upon receipt of this letter, Nihon Kohden''s customer service department will send a replacement unit.

    Distribution

    Nationwide.

    Quantity

    97 units in the U.S.