BEUDAMED
    FDA Enforcement Class II Terminated

    RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.

    Recall: Z-2597-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2597-2014
    Event ID
    68982
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2014
    Initiation Date
    July 28, 2014
    Classification Date
    September 5, 2014
    Termination Date
    October 15, 2014
    Address
    810 Sharon Dr, N/A, Westlake, OH, 44145-1521, United States

    Description

    RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.

    Code Info

    Verions 2.4X, 2.5X and 2.6X

    Distribution

    Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.

    Quantity

    N/A