BEUDAMED
    FDA Recall Terminated

    GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.

    Recall: Z-1884-2008 · Initiated August 12, 2008

    Recall

    Recall Number
    Z-1884-2008
    Event Number
    49486
    Firm
    OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 12, 2008
    Posted
    September 25, 2008
    Terminated
    April 23, 2012
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.

    Reason

    Beam limitation may be non-compliant on some X-ray units.

    Action

    Consignees were notified by letter on 08/12/2008. GE service representatives will check proper beam compliance on next scheduled maintenance visit or will schedule a visit to address the issue. Information available at 1-800-874-7378.

    Distribution

    Nationwide

    Quantity

    201 systems