BEUDAMED
    FDA Enforcement Class II Terminated

    EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.

    Recall: Z-2072-2012 · Reported October 10, 2012

    Enforcement

    Recall Number
    Z-2072-2012
    Event ID
    62621
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Eos Imaging Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2012
    Initiation Date
    June 19, 2012
    Classification Date
    September 28, 2012
    Termination Date
    September 16, 2013
    Address
    185 Alewife Brook Pkwy Ste 410, N/A, Cambridge, MA, 02138-1104, United States

    Description

    EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.

    Reason

    It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.

    Code Info

    All associated Serial Numbers

    Distribution

    Nationwide distribution

    Quantity

    12 EOS Systems installed in the US