BEUDAMED
    FDA Enforcement Class II Terminated

    EOS System X- ray beam Digital radiography system used in general radiographic examinations.

    Recall: Z-0529-2014 · Reported January 15, 2014

    Enforcement

    Recall Number
    Z-0529-2014
    Event ID
    66833
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EOS Imaging
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2014
    Initiation Date
    November 7, 2013
    Classification Date
    January 9, 2014
    Termination Date
    January 27, 2015
    Address
    10 rue Mercoeur 4 Ieme Etage, Paris France, N/A, France

    Description

    EOS System X- ray beam Digital radiography system used in general radiographic examinations.

    Reason

    EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.

    Code Info

    EOS System

    Distribution

    Nationwide Distribution

    Quantity

    22 EOS systems are installed in US