BEUDAMED
    FDA Recall Terminated

    83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.

    Recall: Z-0770-2007 · Initiated December 12, 2005

    Recall

    Recall Number
    Z-0770-2007
    Event Number
    37702
    Firm
    Custom Ultrasonics, Inc.
    FEI Number
    2523209
    Product Code
    FEB
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    December 12, 2005
    Posted
    May 4, 2007
    Terminated
    February 20, 2013
    Address
    144 Railroad Dr, Ivyland, PA, 18974-1449

    Description

    83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.

    Reason

    The device was marketed without a 510k

    Action

    On 12/12/05, the recalling firm telephoned their sales representatives to inform them of the problem. Letter were hand delivered to the hospitals by the sales representatives.

    Distribution

    Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.

    Quantity

    4 units