BEUDAMED
    FDA Enforcement Class II Ongoing

    RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.

    Recall: Z-1281-2021 · Reported March 31, 2021

    Enforcement

    Recall Number
    Z-1281-2021
    Event ID
    87471
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 31, 2021
    Initiation Date
    March 3, 2021
    Classification Date
    March 19, 2021
    Address
    Sveavagen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.

    Reason

    Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

    Code Info

    S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;

    Distribution

    US Nationwide distribution in the state of TN.

    Quantity

    1 unit