BEUDAMED
    FDA Recall Open, Classified

    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

    Recall: Z-2597-2025 · Initiated August 13, 2025

    Recall

    Recall Number
    Z-2597-2025
    Event Number
    97468
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 13, 2025
    Posted
    September 19, 2025
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

    Reason

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

    Action

    Philips Medical notified consignees on about 08/11/2025 via letter. Consignees were instructed that they could continue using the affected systems accordance with the intended use and by following the recommendation: Observe the warning listed in Instructions for Use (IFU) and make sure that the patient is strapped securely to avoid dangling of the hands. Ensure that the patient is placed securely on the patient table and is not in danger of falling. Additionally, consignees were instructed to complete and return the provided response form, to circulate Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue and retain this letter with your system(s) until your system is inspected and corrected if necessary. Philips will contact consignees to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and to inspect the affected system (FCO 72800832) and correct the system if necessary (FCO 72800833).

    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

    33 units