BEUDAMED
    FDA Enforcement Class II Terminated

    Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693

    Recall: Z-0861-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0861-2022
    Event ID
    89595
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remote Diagnostic Technologies Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 13, 2022
    Initiation Date
    January 28, 2022
    Classification Date
    April 4, 2022
    Termination Date
    July 25, 2024
    Address
    PAVILION C2, ASHWOOD PARK, ASHWOOD WAY, Basingstoke, N/A, United Kingdom

    Description

    Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693

    Reason

    Distribution of Defibrillators that are not approved or cleared for distribution US Market.

    Code Info

    Device Serial Numbers 7021.002073 and 7021.002074

    Distribution

    US Nationwide distribution in the states of IL and KS.

    Quantity

    2