BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0319-2024 · Reported November 22, 2023

    Enforcement

    Recall Number
    Z-0319-2024
    Event ID
    93362
    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 16, 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

    This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

    Code Info

    UDI-DI: 00884838103627; Lot Code: 1005

    Distribution

    US Nationwide distribution in the state of MN.

    Quantity

    1 unit