BEUDAMED
    FDA Enforcement Class II Ongoing

    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C

    Recall: Z-0913-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0913-2023
    Event ID
    91296
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2023
    Initiation Date
    December 3, 2022
    Classification Date
    January 6, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568, United States

    Description

    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C

    Reason

    Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

    Code Info

    GTIN 00643169890961: Lot/Serial Numbers: NPL1000794, NPL1002295, NPL1002284, NPL1002272, NPL1001670, NPL1001615, NPL1001596, NPL1001588, NPL1001591, NPL1001592, NPL1001583, NPL1001579, NPL1001558, NPL1000777, NPL1000774, NPL1000776, NPL1000453, NPL1000429,

    Distribution

    Worldwide distribution.

    Quantity

    18 units