BEUDAMED
    FDA Recall Terminated

    MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer

    Recall: Z-0661-2007 · Initiated February 5, 2007

    Recall

    Recall Number
    Z-0661-2007
    Event Number
    37452
    Firm
    Sonosite, Inc.
    FEI Number
    3002087856
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 5, 2007
    Posted
    March 29, 2007
    Terminated
    June 1, 2007
    Address
    21919 30th Dr Se, Bothell, WA, 98021-3904

    Description

    MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer

    Reason

    Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.

    Action

    On 2/5/2007 firm sent by FED-Ex notification letters to firm representatives. Representatives began hand delivery of recall letter to consignees and retrieval of LAP transducer for return delivery to firm. The letter advised customers that the LAP transducer exceeded the limits specified for radio-frequency emissions. The firm also advised that exceeding the limit may cause the LAP transducer to interfere with surrounding equipment that may be susceptible to radiated emissions and cause surrounding equipment to not perform as expected.

    Distribution

    Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.

    Quantity

    6 Devices