BEUDAMED
    FDA Recall Terminated

    FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.

    Recall: Z-0486-2009 · Initiated October 8, 2008

    Recall

    Recall Number
    Z-0486-2009
    Event Number
    50086
    Firm
    FHC, Inc.
    FEI Number
    3002250546
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 8, 2008
    Posted
    December 22, 2008
    Terminated
    May 2, 2012
    Address
    1201 Main Street, Bowdoinham, ME, 04008

    Description

    FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.

    Reason

    Measuring fixture is incorrectly graduated.

    Action

    FHC provided letter notification to FHC Field Representatives on 10/08/08 to hand deliver to customers. FHC Field Representatives will remove incorrectly marked product and provide replacement product. Direct questions to an FHC representative or FHC Quality and Regulatory Affairs at 207-666-5651, ext. 2210.

    Distribution

    Nationwide Distribution including states of CO, FL, NC and NM.

    Quantity

    5 units