BEUDAMED
    FDA Enforcement Class II Ongoing

    Functional MR V1.0

    Recall: Z-0122-2024 · Reported October 25, 2023

    Enforcement

    Recall Number
    Z-0122-2024
    Event ID
    93049
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    OLEA MEDICAL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 25, 2023
    Initiation Date
    August 10, 2023
    Classification Date
    October 18, 2023
    Address
    93 AVANUE DU SORBIER,, ZONE ATHELIA IV, LA CIOTAT, N/A, N/A, France

    Description

    Functional MR V1.0

    Reason

    When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.

    Code Info

    UDI-DI: EOLEFMRIV1P00, Software Versions: V1.0, V1.0 SP1, V1.0 SP2, V1.0 SP3

    Distribution

    US: MI, MA

    Quantity

    2