BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated October 31, 2024

    Recall

    Recall Number
    Z-0678-2025
    Event Number
    95673
    Firm
    Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden
    FEI Number
    3002831423
    Product Code
    KPS
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 31, 2024
    Posted
    December 12, 2024

    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.

    Action

    On 10/31/2024, the firm emailed a "Field Safety Notice (FSN)" letter to customers informing them that when reconstructing a SPECT/CT study, in some cases, the SPECT and CT series are not correctly aligned. This may be due to separately performed acquisitions, or due to the camera operator re-setting the reference point (landmark) between SPECT and CT acquisitions. Normally, the Hybrid Recon application warns the user if the Frames of Reference do not match, however in some configurations this warning message may be turned off. Customers are instructed how to avoid the problem by: In all cases, the user must verify correct SPECT to CT alignment by careful inspection of the fused images during reconstruction. To ensure that you are warned about possible SPECT to CT misalignment, the Skip Frame of Reference warning radio button shall not be set on . The Skip Frame of Reference warning radio button can be found in the Program Parameters window (button at top right corner of the window left side of the ? symbol). Go to the Recon tab and find the Skip frame of reference warning radio button. If the button is on as shown here, this warning will not be shown to the users. The setting of the Skip Frame of Reference warning radio button should be checked to ensure it is off for each workflow Oncology, Neurology, Cardiology and Lung. Please contact your Hermes Medical Solutions support if you do not have permission to make the changes required. For questions or further assistance contact General: [email protected] Canada: [email protected] USA: [email protected]

    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