BEUDAMED
    FDA Enforcement Class II Terminated

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    Recall: Z-1193-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1193-2016
    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 2412 ( 2 x 12 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: 03EDB5, 03EDD9, 03EDDA, 03EDDB, 03EDDD, 03EDE0, 03EDE4, 03EDF5, 03EDF6, 03EDFA, 03EDFC, 03EDFF, 03EE07, 03EE08, 03EE0A, 03EE0D, 03EE0E, 03EE12, 03EE13, 03EE1A, 03EE30, 03EE3C, 03EE3F, 03EE44, 03EE48, 03EE4C, 03EE4D, 03EE6D, 03EE74, 03EE82, 03EE88, 03EE89, 03EE8F, 03EE94.

    Distribution

    Distributed in Germany and Luxembourg.

    Quantity

    34