BEUDAMED
    FDA Enforcement Class II Terminated

    EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

    Recall: Z-1068-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1068-2015
    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 Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

    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

    928 units