BEUDAMED
    FDA Enforcement Class II Ongoing

    IntelePACS (Image Fusion Module) - InteleViewer

    Recall: Z-1208-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1208-2025
    Event ID
    96270
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    INTELERAD MEDICAL SYSTEMS INCORPORATED
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2025
    Initiation Date
    February 5, 2025
    Classification Date
    February 21, 2025
    Address
    800, Boul. de Maisonneuve Est, 12th floor, Montreal, N/A, N/A, Canada

    Description

    IntelePACS (Image Fusion Module) - InteleViewer

    Reason

    A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.

    Code Info

    UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, NC, MI, FL, NH, WY, CA, SC, AL, AR, IN, MD, CO, TN, IL, NJ, OH, MN, WV, KE, NE, VA, WA, GE, WI and the countries of New Zealand, Canada, Australia

    Quantity

    88