BEUDAMED
    FDA Enforcement Class II Ongoing

    Spectral CT 7500 on Rails; Product Code (REF): 728334;

    Recall: Z-1318-2026 · Reported February 18, 2026

    Enforcement

    Recall Number
    Z-1318-2026
    Event ID
    98248
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2026
    Initiation Date
    January 7, 2026
    Classification Date
    February 6, 2026
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Spectral CT 7500 on Rails; Product Code (REF): 728334;

    Reason

    As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

    Code Info

    Product Code (REF): 728334; UDI-DI: 00884838103627; Serial Numbers: 1005, 1007, 1008;

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Macao, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkmenistan, United Kingdom, Uzbekistan, Vietnam.

    Quantity

    3 units