BEUDAMED
    FDA Enforcement Class II 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 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0581-2016
    Event ID
    72763
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    November 11, 2015
    Classification Date
    January 4, 2016
    Termination Date
    October 3, 2016
    Address
    2568 Bristol Cir, N/A, Oakville, N/A, N/A, 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.

    Code Info

    Serial Number 013926020008 013926020009 013926020006 013926020016 013926020014 013926030024 013926030031 013926020001 013926020004 013926030059 013926030060 013926030074 013926030075 013926030052 013926030017 013926030018 013926030021 013926030053 013926030101 013926030058 013926030019 013926030038 013926030039 013926030044 013926020015 013926030097 013926020013 013926030055 013926030056 013926030081 013926030096 013926030078 013926030048 013926030057 013926030064 013926030047 013926030027 013926030025 013926030042 013926030023 013926030030 013926030036 013926030026 013926030050 013926030080 013926030099 013926030035 013926030046 013926030049 013926030073 013926030020 013926030092 013926030040 013926030041 013926030061 013926030062

    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)