BEUDAMED
    FDA Recall Terminated

    Nicolet Ambulatory EEG

    Recall: Z-2568-2018 · Initiated February 1, 2018

    Recall

    Recall Number
    Z-2568-2018
    Event Number
    80023
    Firm
    Natus Neurology Inc
    FEI Number
    3010611950
    Product Code
    OLV
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 1, 2018
    Terminated
    October 21, 2022
    Address
    3150 Pleasant View Rd, Middleton, WI, 53562-4800

    Description

    Nicolet Ambulatory EEG

    Reason

    Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

    Action

    Customers were notified via letter on about 02/01/2018. Instructions to ensure the empty exam is removed appropriately after starting the ambulatory recording included: 1) Only shutdown Recorder via the Recorder UI, either from the File menu or the X button on the top right of the application; 2) If any of the four conditions above occurs and the 2.60 MB exam is not removed, the empty exam can be deleted from NicVue prior to importing the ambulatory exam, doing so will allow the patient ID check to occur normally. Customers were also instructed to provide the recall communication to all applicable users and complete and return the verification form.

    Distribution

    Distributed domestically to AR, AZ, CA, CO, DC, FL, GA, ID, IL, IN, MA, ME, MI, MO, N Y, NC, ND, NJ, NV, NY, PA, TN, TX, VA, WA, WI. Distributed internationally to Australia, Belgium, China, Germany, Hong Kong, Israel, Italy, Jordan, Kuwait, Russia, Slovenia, Tunisia, United Arab Emirates, Vietnam.

    Quantity

    171 units