BEUDAMED
    FDA Enforcement Class II Ongoing

    Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery

    Recall: Z-0209-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0209-2025
    Event ID
    95322
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Blue Ortho
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 30, 2024
    Initiation Date
    August 30, 2024
    Classification Date
    October 24, 2024
    Address
    22 Chemin Du Vieux Chene, N/A, Meylan, N/A, N/A, France

    Description

    Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery

    Reason

    Predict+ is being recalled for lack of pre-market clearance/approval.

    Code Info

    Software version v1.3

    Distribution

    US Nationwide distribution.

    Quantity

    136 software units