BEUDAMED
    FDA Enforcement Class II Terminated

    EOS, Digital radiography system used in general radiographic examinations.

    Recall: Z-1460-2015 · Reported May 13, 2015

    Enforcement

    Recall Number
    Z-1460-2015
    Event ID
    70732
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Eos Imaging Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2015
    Initiation Date
    February 17, 2015
    Classification Date
    May 5, 2015
    Termination Date
    May 31, 2017
    Address
    185 Alewife Brook Pkwy Ste 410, N/A, Cambridge, MA, 02138-1104, United States

    Description

    EOS, Digital radiography system used in general radiographic examinations.

    Reason

    When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.

    Code Info

    Model Number - EOS System

    Distribution

    US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.

    Quantity

    13 units installed in US