BEUDAMED
    FDA Enforcement Class II Terminated

    AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

    Recall: Z-3052-2020 · Reported October 7, 2020

    Enforcement

    Recall Number
    Z-3052-2020
    Event ID
    86282
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ESAOTE S.P.A
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 7, 2020
    Initiation Date
    September 8, 2020
    Classification Date
    September 30, 2020
    Termination Date
    April 17, 2023
    Address
    Via Enrico Melen 77, N/A, Genova, N/A, N/A, Italy

    Description

    AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

    Reason

    The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use.

    Code Info

    Serial Numbers: Below K17510001

    Distribution

    US Nationwide

    Quantity

    989 total adapters in the US