BEUDAMED
    FDA Recall 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 · Initiated January 3, 2018

    Recall

    Recall Number
    Z-1138-2018
    Event Number
    79547
    Firm
    ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy
    FEI Number
    3012981490
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 3, 2018
    Terminated
    May 30, 2019

    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.

    Action

    The January 3, 2018, notification letter requests the consignee complete and return a recall response form. The letter states that Esaote customer service will contact the consignee about the software update. In the meantime, it is recommended that the consignee does not use the PA023E probe in Pulsed Wave (PW) Doppler mode and that they refrain from using the system in Elaxto mode where the patient is unconscious or sedated. The consignee is asked to check the temperature of the probe before use.

    Distribution

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

    Quantity

    5