BEUDAMED
    FDA Recall Terminated

    Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

    Recall: Z-0946-2013 · Initiated February 27, 2013

    Recall

    Recall Number
    Z-0946-2013
    Event Number
    64479
    Firm
    Natus Neurology Incorporated
    FEI Number
    3010611950
    Product Code
    GWL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 27, 2013
    Posted
    March 13, 2013
    Terminated
    April 25, 2014
    Address
    1850 Deming Way, Middleton, WI, 53562-3530

    Description

    Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

    Reason

    Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.

    Action

    Natus sent an "Urgent Medical Device Correction and Removal Notification' letter dated February 27, 2013 to all affected customers. The letter described the affected product, problem and actions to be taken. The letter advised customers that a Natus Field Service technician will remove and replace the affected product at no charge to the users. The letter also advised if any of the affected products have been transferred to another location to please forward a copy of the letter and to notify Natus. For questions call 800-356-0007 ext. 5129.

    Distribution

    Worldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDONESIA IRELAND ITALY JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS ROMANIA RUSSIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM URUGUAY VIET NAM

    Quantity

    114 (31 USA; 83 OUS)