BEUDAMED
    FDA Enforcement Class II Ongoing

    Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

    Recall: Z-1181-2024 · Reported February 28, 2024

    Enforcement

    Recall Number
    Z-1181-2024
    Event ID
    93988
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PTW-FREIBURG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 28, 2024
    Initiation Date
    February 8, 2024
    Classification Date
    February 22, 2024
    Address
    Lorracher Str. 7, N/A, Freiburg Im Breisgau, N/A, N/A, Germany

    Description

    Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

    Reason

    Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.

    Code Info

    UDI-DI: EPTWS070031 Software VERIQA (S070031), version 2.0 and 2.1

    Distribution

    GA

    Quantity

    1 US; 65 worldwide