BEUDAMED
    FDA Recall Terminated

    GE Healthcare OEC 9900 mobile fluoroscopic x-ray system

    Recall: Z-0368-2008 · Initiated December 14, 2007

    Recall

    Recall Number
    Z-0368-2008
    Event Number
    49536
    Firm
    OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 14, 2007
    Posted
    September 29, 2008
    Terminated
    April 13, 2012
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE Healthcare OEC 9900 mobile fluoroscopic x-ray system

    Reason

    Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected.

    Action

    GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.

    Distribution

    Worldwide distribution: USA, Finland, Netherlands, Germany, Switzerland, France, United Kingdom, Australia, Italy, Ireland, Spain, Sweden, Belgium, New Zealand, China, Singapore, Poland, Norway, and India.

    Quantity

    710