BEUDAMED
    FDA Recall Terminated

    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.

    Recall: Z-0581-2016 · Initiated November 11, 2015

    Recall

    Recall Number
    Z-0581-2016
    Event Number
    72763
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    FEI Number
    3002809369
    Product Code
    GWQ
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    November 11, 2015
    Terminated
    October 3, 2016
    Address
    2568 Bristol Cir, Oakville Canada

    Description

    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.

    Reason

    During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.

    Action

    The firm, Natus Neurology, sent an "Urgent Medical Device Correction Notification" letter on 11/11/2015. The letter described the the problem, the product involved in the recall and actions to be taken. Natus will provide further information once an updated software is released. The consignees were instructed to complete and return the confirmation form by mail to Senior Manager Quality and Regulatory Affairs, Excel-Tech, Ltd (XLTEK) Division, Natus Medical Incorporated, 2568 Bristol Circle, Oakville, ON L6H 5S1 or by email to :[email protected]. If you have any questions, contact Senior Manager Quality and Regulatory Affairs at 905-287-5055 or email: [email protected].

    Distribution

    Worldwide Distribution: US Distribution including states of: AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX and UT; and countries of: INDIA, KOREA, SPAIN, SWITZERLAND, THAILAND, UNITED KINGDOM, and CANADA. .

    Quantity

    56 (43 US, 13 OUS)