BEUDAMED
    FDA Enforcement Class II Ongoing

    Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0

    Recall: Z-0678-2025 · Reported December 18, 2024

    Enforcement

    Recall Number
    Z-0678-2025
    Event ID
    95673
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hermes Medical Solutions AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2024
    Initiation Date
    October 31, 2024
    Classification Date
    December 12, 2024
    Address
    Strandbergsgatan 16, Stockholm, N/A, Sweden

    Description

    Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0

    Reason

    Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.

    Code Info

    Hermes Medical Imaging System version 6.1 with Hybrid Recon version 4.0.x UDI-DI code: 00859873006158 Serial Numbers: Pending Hybrid Recon version 5.0.0 UDI code: (01)00859873006196(8012)005000000 Serial Numbers: Pending

    Distribution

    U.S.: CA, CT, FL, HI, KY, MA, MD, MO, NJ. NY, OH, TN, TX, VA, and WA O.U.S.: Germany, and United Kingdoms

    Quantity

    778 systems