BEUDAMED
    FDA Recall Terminated

    MyLab25 Ultrasound Imaging System; Model 9807300002.

    Recall: Z-1403-05 · Initiated May 6, 2005

    Recall

    Recall Number
    Z-1403-05
    Event Number
    32019
    Firm
    Biosound Esaote, Inc.
    FEI Number
    1826555
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 6, 2005
    Posted
    August 25, 2005
    Terminated
    October 25, 2005
    Address
    8000 Castleway Dr, Indianapolis, IN, 46250-1943

    Description

    MyLab25 Ultrasound Imaging System; Model 9807300002.

    Reason

    Data may be corrupted upon re-opening archived files.

    Action

    U.S. distributors were notified via recall letter dated 5/2/05 and U.S. customers were notified via letter dated 5/6/05. Canadian customer were notified via letter dated 5/13/05 and Puerto Rico distributor and customers were ntofied on 5/9/05. The firm is installing new software in the field.

    Distribution

    Nationwide, Canada and Venezuela.

    Quantity

    10