BEUDAMED
    FDA Enforcement Class II Ongoing

    Intelerad InteleShare software, with ProViewer component

    Recall: Z-0941-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0941-2026
    Event ID
    97993
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DICOM Grid, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    December 24, 2025
    Initiation Date
    November 18, 2025
    Classification Date
    December 18, 2025
    Address
    305 Church At North Hills St, Raleigh, NC, 27609-5177, United States

    Description

    Intelerad InteleShare software, with ProViewer component

    Reason

    Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.

    Code Info

    Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0

    Distribution

    US: AZ, TX, GA, NV, MO, MI, IL, OH, CT, OR, FL, NY, NM, MN, PA, AK, ND, NJ, VA, WA, NC, TN, WI, GA, AK, CA, SD, CO, MA, WV, MN, KS, MD, VT, IA, RI, AL, ID, LA, PR, NH, IN, OK, UT, NE, SC, AR, DE OUS: CA, NZ, AU, GB, BE, FR, IT, NO, SE

    Quantity

    924