BEUDAMED
    FDA Enforcement Class II Ongoing

    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143

    Recall: Z-1871-2024 · Reported May 29, 2024

    Enforcement

    Recall Number
    Z-1871-2024
    Event ID
    94536
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2024
    Initiation Date
    April 15, 2024
    Classification Date
    May 20, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289, United States

    Description

    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143

    Reason

    Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity

    Code Info

    UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers- Applied to FCO72800819: 500046, 500064, 500074, 500102, 500110, 500111, 500145, 500168, 500178, 500211 500216, 500217, 500222, 500225, 500230, 500240, 500242. Serial Number-Applied to FCO72800820 : 500615

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    18 units