BEUDAMED
    FDA Enforcement Class II Ongoing

    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

    Recall: Z-0306-2024 · Reported November 22, 2023

    Enforcement

    Recall Number
    Z-0306-2024
    Event ID
    93363
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 22, 2023
    Initiation Date
    October 9, 2023
    Classification Date
    November 15, 2023
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States

    Description

    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

    Reason

    When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

    Code Info

    UDI-DI: 00884838103627; Lot Code: 1005

    Distribution

    US Nationwide distribution in the state of MN.

    Quantity

    1 unit