BEUDAMED
    FDA Recall Terminated

    GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah

    Recall: Z-0850-2007 · Initiated June 12, 2007

    Recall

    Recall Number
    Z-0850-2007
    Event Number
    38279
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 12, 2007
    Posted
    June 30, 2007
    Terminated
    November 1, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah

    Reason

    X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

    Action

    Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.

    Distribution

    Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.

    Quantity

    22 units