BEUDAMED
    FDA Recall Terminated

    iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538

    Recall: Z-1693-2008 · Initiated April 11, 2000

    Recall

    Recall Number
    Z-1693-2008
    Event Number
    47759
    Firm
    Boston Scientific Corporation
    FEI Number
    2939204
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 11, 2000
    Posted
    September 23, 2008
    Terminated
    April 6, 2009
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515

    Description

    iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538

    Reason

    Improperly terminated wires on a component of the iLab Acquisition processor power supply could cause the processor to lock-up or stop, and prolong the patients procedure.

    Action

    On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008.

    Distribution

    Product was distributed to a total of 81 consignees in the USA, Hong Kong, Great Britain, Austria and France.

    Quantity

    120 units