BEUDAMED
    FDA Enforcement Class III Ongoing

    Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode

    Recall: Z-0557-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0557-2025
    Event ID
    95642
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remote Diagnostic Technologies Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 28, 2024
    Classification Date
    November 26, 2024
    Address
    Farnborough Aerospace Centre, Aerospace Boulevard, Farnborough, N/A, United Kingdom

    Description

    Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode

    Reason

    Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

    Code Info

    Model Number: 00-3020 UDI-DI code: 07613365002737 Serial Numbers: 7022.000367 7022.000387 7022.000392 7022.000462 7022.000463 7022.000464 7022.000559 7022.000591 7022.000595 7022.000711 7022.000781 7022.000786 7022.00108 7022.001175 7022.001201 7022.00129 7022.001556 7022.001582

    Distribution

    U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.