BEUDAMED
    FDA Recall Terminated

    LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 Channel Breast Biopsy Lateral Grids (pack of 5 grids) or 2) the plate is purchased in pairs with the following part numbers: M3087JG, which contains Liberty 9000 8-Channel Breast Coil, 2 plates and a manual; G3087JH, which contains 2 plates and a manual; M3335LA, which contains a 3T HD 8 channel Vibrant Breast Array, 2 plates and a manual.

    Recall: Z-0505-2007 · Initiated November 21, 2006

    Recall

    Recall Number
    Z-0505-2007
    Event Number
    36866
    Firm
    USA Instruments Incorporated
    FEI Number
    3005214683
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 21, 2006
    Posted
    February 15, 2007
    Terminated
    April 13, 2012
    Address
    1515 Danner Dr, Aurora, OH, 44202-9273

    Description

    LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 Channel Breast Biopsy Lateral Grids (pack of 5 grids) or 2) the plate is purchased in pairs with the following part numbers: M3087JG, which contains Liberty 9000 8-Channel Breast Coil, 2 plates and a manual; G3087JH, which contains 2 plates and a manual; M3335LA, which contains a 3T HD 8 channel Vibrant Breast Array, 2 plates and a manual.

    Reason

    The packaging used for the Breast Biopsy Plate may exhibit small holes or tears.

    Action

    Customers were notifed by certified letter, dated 11/28/06.

    Distribution

    Nationwide.

    Quantity

    250 units