BEUDAMED
    FDA Enforcement Class II Ongoing

    LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

    Recall: Z-1216-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1216-2023
    Event ID
    91646
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2023
    Initiation Date
    February 2, 2023
    Classification Date
    March 3, 2023
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700, United States

    Description

    LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

    Reason

    Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..

    Code Info

    UDI-DI: 00802526613876

    Distribution

    US Nationwide distribution to the healthcare facilities and healthcare providers are located in CA, CO, DE, FL, GA, ID, IL, IN, IA, KY, ME, MD, MA, NV, NH, NJ, NY, NC, OH, PA, RI, SC, TN TX, VA, WA, WV, and WI.

    Quantity

    1,531 patient data records