BEUDAMED
    FDA Recall Terminated

    Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.

    Recall: Z-0816-2018 · Initiated October 20, 2017

    Recall

    Recall Number
    Z-0816-2018
    Event Number
    79160
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    October 20, 2017
    Terminated
    April 16, 2020
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.

    Reason

    The ultrasound probe may not have adequate protection against electrical shock hazards.

    Action

    Hitachi must recall the lot of UST-5550-R Transducers from S/N 1 to S/N 155. If you have a serial number in this range, please contact Hitachi Service at (800) 800-4925 to schedule the recall. Hitachi Sales will contact you regarding the options for a replacement transducer.

    Distribution

    Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.

    Quantity

    55