BEUDAMED
    FDA Recall Terminated

    Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.

    Recall: z-2640-2010 · Initiated July 15, 2010

    Recall

    Recall Number
    z-2640-2010
    Event Number
    56652
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    LFL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 15, 2010
    Posted
    October 1, 2010
    Terminated
    October 19, 2011
    Address
    4100 E. Milham Ave., Kalamazoo, MI, 49001

    Description

    Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.

    Reason

    Stryker Instruments acquired the Sonopet Ultrasonic Surgical System from Mutoh co. Ltd on 3/29/2010. Stryker determined that the Sonopet consode did not meet the IEC-60601-1 standard. Stryker decided to recall the Sonopet consode.

    Action

    The firm to send URGENT MEDICAL DEVICE RECALL NOTIFICATIONS to customers dated 7/15/2010. The customers were instructed to continue to use the device. Stryker technicians were dispatched to replace a board with a new board.

    Distribution

    Wordwide

    Quantity

    1161