BEUDAMED
    FDA Recall Terminated

    Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging

    Recall: Z-2167-2014 · Initiated June 26, 2014

    Recall

    Recall Number
    Z-2167-2014
    Event Number
    68648
    Firm
    Biosound Esaote, Inc.
    FEI Number
    1826555
    Product Code
    JOP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 26, 2014
    Posted
    August 8, 2014
    Terminated
    July 17, 2015
    Address
    8000 Castleway Dr, Indianapolis, IN, 46250-1943

    Description

    Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging

    Reason

    Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.

    Action

    On 06/26/2014, Esaote North America sent an advisory letter via FEDEX (with signature required) to each customer or consignee affected by this voluntary recall. The packet contained the advisory letter, including actions to be taken by the user, information about a pending software upgrade, and a business reply card to confirm they received the letter and have the equipment noted on the advisory letter. Customers with questions were instructed to call 800-428-7378. For questions regarding this recall call 1-317-813-6005

    Distribution

    Nationwide-Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV. International**Product was also shipped to consignees in Canada

    Quantity

    1,301 units