BEUDAMED
    FDA Enforcement Class II Ongoing

    Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R

    Recall: Z-2175-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2175-2025
    Event ID
    97197
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remote Diagnostic Technologies Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    May 30, 2025
    Classification Date
    July 25, 2025
    Address
    Farnborough Aerospace Centre, Aerospace Boulevard, Farnborough, N/A, United Kingdom

    Description

    Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R

    Reason

    Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.

    Code Info

    REF/UDI-DI: 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932. Software Version: vx.28

    Distribution

    Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.

    Quantity

    55