BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2072-2012 · Initiated June 19, 2012

    Recall

    Recall Number
    Z-2072-2012
    Event Number
    62621
    Firm
    Eos Imaging Inc
    FEI Number
    3008632827
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    June 19, 2012
    Posted
    September 28, 2012
    Terminated
    September 16, 2013
    Address
    185 Alewife Brook Pkwy, Ste 410, Cambridge, MA, 02138-1104

    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.

    Action

    EOS Imaging notified users by letter on 6/19/12 and that an on site correction would be performed by an EOS Imaging Field Service engineer. EOS indicated in its notification that although this specific defect has not been observed in EOS systems installed in the U.S, they will replace the anode driver boards with new boards equipped with high current capacitors. Similarly, the generator firmware will be upgraded with the software patch that improves the cooling fans' controls. This will be replaced at no charge to the customers, during regularly scheduled preventative maintenance of the user's EOS system. This should be completed by the end of calendar year 2012. Your proposed CAP appears to adequately address the issues you raised in your notification, and is hereby approved. Your proposed customer notification letter as revised, appears to adequately provide instructions with respect to the use of the product pending the correction of the defect and it appears to provide a clear evaluation in nontechnical terms of the potential hazards related to the defect. Your proposed notification letter is hereby approved for distribution to all affected parties. Further questions please call 678-564-5400.

    Distribution

    Nationwide distribution

    Quantity

    12 EOS Systems installed in the US