BEUDAMED
    FDA Enforcement Class II Terminated

    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

    Recall: Z-0580-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0580-2014
    Event ID
    66980
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EOS Imaging
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    November 29, 2013
    Classification Date
    December 26, 2013
    Termination Date
    January 13, 2015
    Address
    10 rue Mercoeur 4 Ieme Etage, N/A, Paris France, N/A, N/A, France

    Description

    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

    Reason

    Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation

    Code Info

    Software versions: 1.3, 1.4 and 1.5

    Distribution

    USA Nationwide Distribution

    Quantity

    36 units