BEUDAMED
    FDA Recall Terminated

    The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The large grid biopsy plate is packaged and sold as a part of catalogue 2414798 and 2415277.

    Recall: Z-0519-2007 · Initiated January 31, 2007

    Recall

    Recall Number
    Z-0519-2007
    Event Number
    37263
    Firm
    USA Instruments Incorporated
    FEI Number
    3005214683
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 31, 2007
    Posted
    February 15, 2007
    Terminated
    April 13, 2012
    Address
    1515 Danner Dr, Aurora, OH, 44202-9273

    Description

    The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The large grid biopsy plate is packaged and sold as a part of catalogue 2414798 and 2415277.

    Reason

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

    Action

    The recalling firm notified consignees via certified letter, dated 1/31/07.

    Distribution

    Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.

    Quantity

    Approximately 2200 units for all products being recalled