BEUDAMED
    FDA Enforcement Class II Terminated

    EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)

    Recall: Z-1256-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1256-2020
    Event ID
    84790
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edan Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 26, 2020
    Initiation Date
    November 17, 2017
    Classification Date
    February 18, 2020
    Termination Date
    September 28, 2022
    Address
    9833 Pacific Heights Blvd, San Diego, CA, 92121-4707, United States

    Description

    EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)

    Reason

    Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.

    Code Info

    Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002

    Distribution

    U.S. Nationwide distribution in the state of CA.

    Quantity

    7 units