BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

    Recall: Z-2601-2025 · Reported October 1, 2025

    Enforcement

    Recall Number
    Z-2601-2025
    Event ID
    97468
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2025
    Initiation Date
    August 13, 2025
    Classification Date
    September 19, 2025
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

    Reason

    The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

    Code Info

    1. Model Number: 728332; UDI-DI: 00884838059542; Serial Numbers: 860088, 860023, 860077, 860086, 60019, 860152, 860215, 60031, 60123, 60129, 60152, 860011, 860049, 860019, 860008, 860030, 860025, 860009, 860022, 860013, 860024, 860020, 860036, 860041, 860046, 860055, 860058, 860054, 860073, 860065, 860070, 860072, 860066, 860103, 860076, 860085, 860095, 860102, 860101, 860104, 860175, 860136, 860117, 860120, 860121, 860124, 860125, 860191, 860131, 860150, 860164, 60041, 860207, 60003, 860157, 860167, 860158, 860196, 60012, 860176, 860185, 860168, 860179, 860194, 60010, 60013, 60007, 60001, 395003, 860209, 860208, 60036, 60030, 60027, 60054, 60055, 60053, 60058, 60079, 395005, 60145.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

    Quantity

    81 units