BEUDAMED
    FDA Enforcement Class II Ongoing

    Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).

    Recall: Z-1997-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1997-2021
    Event ID
    88051
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remote Diagnostic Technologies Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 7, 2021
    Initiation Date
    May 25, 2021
    Classification Date
    July 1, 2021
    Address
    PAVILION C2, ASHWOOD PARK, ASHWOOD WAY, Basingstoke, N/A, N/A, United Kingdom

    Description

    Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).

    Reason

    The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.

    Code Info

    Software version number: v07.00, v07.01, v07.18, v07.20, v07.22, v07.24. UDI No. 12NC No. 05060472440020 989706002081 05060472440013 989706000001 05060472441027 989706000051 05060472441058 989706000101

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, TX, PA, MN, UT, MT, CA, WI, VA, NY, TN, KS, MD and the countries of Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, UK.

    Quantity

    510 systems