BEUDAMED
    FDA Enforcement Class II Terminated

    Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

    Recall: Z-1194-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1194-2016
    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 External Pulse Generator, Trial Stimulator, Model 3400

    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: 01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6, 01DCB

    Distribution

    Distributed in Germany and Luxembourg.

    Quantity

    31