BEUDAMED
    FDA Enforcement Class II Ongoing

    TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.

    Recall: Z-1573-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1573-2023
    Event ID
    92184
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Technidata S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 17, 2023
    Initiation Date
    March 27, 2023
    Classification Date
    May 10, 2023
    Address
    387 Avenue Jean Kuntzmann, N/A, Montbonnot St Martin, N/A, N/A, France

    Description

    TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.

    Reason

    In a specific use case, when printing labels for slides, some labels may display wrong information

    Code Info

    UDI-DI : 03770027519010 All TDHisto/Cyto software versions

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    1 unit