BEUDAMED
    FDA Recall Terminated

    Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66

    Recall: Z-0180-06 · Initiated October 31, 2005

    Recall

    Recall Number
    Z-0180-06
    Event Number
    33946
    Firm
    FHC, Inc.
    FEI Number
    3002250546
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2005
    Posted
    November 23, 2005
    Terminated
    June 7, 2006
    Address
    9 Main St, Bowdoinham, ME, 04008-4418

    Description

    Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66

    Reason

    Power Assist microTargeting System may advance beyond intended target

    Action

    FHC Inc. and Medtronic notified customers by letter and instructs the customer to return their Motor Option for upgrade to include the following components: 1) Handheld Remote Control, 2) Motor Controller Unit with Display, 3) Motor, and 4) Medical Power Adapter. (See pictures at the end of this communication). Until the Motor Option has been updated, instructions to customers are: Prior to each clinical use: Ensure the microTargeting Drive system is calibrated before each clinical use per the User Guide. Check the microTargeting Drive system functionality over a range of at least 10mm movement. Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode. During clinical use: Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode. Every 100 uses or annually: Have your microTargeting Drive system checked by the manufacturer per the User Guide. Have your equipment support department check or tighten the MicroTargeting Drive Motor Option Remote Control Knob set screws, tighten as needed, and then re-calibrate.

    Distribution

    Nationwide Foreign: South Africa, Taiwan, Hong Kong, China, France

    Quantity

    230 units