BEUDAMED
    FDA Enforcement Class I Ongoing

    TruSignal Ear Sensor, REF TS-E-D; Oximeter

    Recall: Z-2030-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2030-2023
    Event ID
    92455
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare Finland Oy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2023
    Initiation Date
    May 19, 2023
    Classification Date
    July 6, 2023
    Address
    Kuortaneenkatu 2, N/A, Helsinki, N/A, N/A, Finland

    Description

    TruSignal Ear Sensor, REF TS-E-D; Oximeter

    Reason

    There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

    Code Info

    GTIN 00840682103251

    Distribution

    Worldwide

    Quantity

    10451 devices