BEUDAMED
    FDA Enforcement Class II Terminated

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

    Recall: Z-1192-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1192-2016
    Event ID
    73150
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    QiG Group LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    January 26, 2016
    Classification Date
    March 18, 2016
    Termination Date
    April 5, 2017
    Address
    10675 Naples St NE, N/A, Blaine, MN, 55449-5802, United States

    Description

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

    Reason

    The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm). The following functions may not be available: Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.

    Code Info

    Serial Numbers: 03EDBF, 03EDC1, 03EDC5, 03EDC7, 03EDC9, 03EDCA, 03EDCE, 03EDD0, 03EDE5, 03EDE8, 03EDE9, 03EDEA, 03EDEF, 03EDF0, 03EE01, 03EE03, 03EE05, 03EE1C, 03EE1F, 03EE24, 03EE25, 03EE26, 03EE28, 03EE34, 03EE35, 03EE36, 03EE37, 03EE3A, 03EE3B, 03EE5A, 03EE5B, 03EE60, 03EE96, 03EE97, 03EE98, 03EE9D, 03EE9F, 03EEA2, 03EEA3, 03EEA4, 03EEAC.

    Distribution

    Distributed in Germany and Luxembourg.

    Quantity

    40