BEUDAMED
    FDA Enforcement Class II Terminated

    EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.

    Recall: Z-1067-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1067-2015
    Event ID
    70157
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Medical Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 18, 2015
    Initiation Date
    January 2, 2015
    Classification Date
    February 9, 2015
    Termination Date
    March 22, 2017
    Address
    2568 Bristol Circle, N/A, Oakville, Ontario, N/A, Canada

    Description

    EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.

    Reason

    Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.

    Code Info

    EPWorks Software Versions prior to 6.0

    Distribution

    US Nationwide Distribution

    Quantity

    248 units