BEUDAMED
    FDA Recall Open, Classified

    Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

    Recall: Z-1055-2024 · Initiated December 13, 2023

    Recall

    Recall Number
    Z-1055-2024
    Event Number
    93798
    Firm
    PHILIPS MEDICAL SYSTEMS
    FEI Number
    3017726341
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 13, 2023
    Posted
    February 8, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

    Reason

    A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

    Action

    An Urgent Medical Device Correction notice (2023-PD-CTAMI-017) dated December 13, 2023 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions.

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.

    Quantity

    US: 33, OUS 177