BEUDAMED
    FDA Enforcement Class II Terminated

    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33

    Recall: Z-1138-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1138-2018
    Event ID
    79547
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ESAOTE S.P.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 28, 2018
    Initiation Date
    January 3, 2018
    Classification Date
    March 20, 2018
    Termination Date
    May 30, 2019
    Address
    Sesto Fiorentino, Via Degli Olmi 11, Sesto Fiorentino, N/A, N/A, Italy

    Description

    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33

    Reason

    The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

    Code Info

    Software versions 12.10 - 13.60

    Distribution

    US distribution in the states: AZ, FL, OK, PA, and TX.

    Quantity

    5