BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1216-2023 · Initiated February 2, 2023

    Recall

    Recall Number
    Z-1216-2023
    Event Number
    91646
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Open, Classified
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    February 2, 2023
    Posted
    March 3, 2023
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    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..

    Action

    The recalling firm issued letters to LATITUDE Healthcare Professionals via third-party Federal Express with signature at the account required on 2/2/2023. The letter informed the HCP that records indicate they may have U.S. patients who do not have HeartLogic enabled as the HCP may have intended in the Model 6460 U.S. LATITUDE NXT Patient Management System. The patients included within the enclosed list are scheduled to have HeartLogic enabled in LATITUDE ON 2/14/2023. The letter provides the clinical impact and recommendations. The recommendations include: (1) Distribute this information to appropriate HCPs within your center who manage HeartLogic alerts for the patients in the enclosed list; and (2) If you do NOT want HeartLogic enabled in LATITUDE for patients in the enclosed list, contact Boston Scientific LATITUDE Customer Support via [email protected] before 2/14/2023 and identify which patients should NOT be enabled. On 2/14/2023, BSC will correct the data on the Model 6460 LATITUDE Server for affected patients, unless a request not to enable is received by the firm prior to this date. Update: on 02/14/2023, Boston Scientific sent an additional letter, due to the original letter being lost in the mail. The revised letter advised customers to email LATITUDE Custoemr Support to have HeartLogic disabled.

    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