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    Hsa 6004101 010 19 18 - 71 FSN - Redacted

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    Hazem Said
    GE Healthcare notified hospital administrators about potential issues with some Revolution CT scanners that could cause additional low-dose radiation exposure to patients. The first issue could delay the transition from monitoring to diagnostic scans during Smart Prep procedures, resulting in extra radiation. The second issue is scout images could become rotated if foot pedals instead of the gantry are used to reposition patients, requiring another scout. As a precaution, hospitals are advised to disable the Real-Time Systems function and only use gantry controls for repositioning until GE provides a correction. GE will remedy any defects without charge to ensure patient safety and compliance with federal standards. Hospitals should contact GE with any questions or concerns.

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    Hsa 6004101 010 19 18 - 71 FSN - Redacted

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    Hazem Said
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    GE Healthcare notified hospital administrators about potential issues with some Revolution CT scanners that could cause additional low-dose radiation exposure to patients. The first issue could delay the transition from monitoring to diagnostic scans during Smart Prep procedures, resulting in extra radiation. The second issue is scout images could become rotated if foot pedals instead of the gantry are used to reposition patients, requiring another scout. As a precaution, hospitals are advised to disable the Real-Time Systems function and only use gantry controls for repositioning until GE provides a correction. GE will remedy any defects without charge to ensure patient safety and compliance with federal standards. Hospitals should contact GE with any questions or concerns.

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    GE Healthcare notified hospital administrators about potential issues with some Revolution CT scanners that could cause additional low-dose radiation exposure to patients. The first issue could delay the transition from monitoring to diagnostic scans during Smart Prep procedures, resulting in extra radiation. The second issue is scout images could become rotated if foot pedals instead of the gantry are used to reposition patients, requiring another scout. As a precaution, hospitals are advised to disable the Real-Time Systems function and only use gantry controls for repositioning until GE provides a correction. GE will remedy any defects without charge to ensure patient safety and compliance with federal standards. Hospitals should contact GE with any questions or concerns.

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    4 views2 pages

    Hsa 6004101 010 19 18 - 71 FSN - Redacted

    Uploaded by

    Hazem Said
    GE Healthcare notified hospital administrators about potential issues with some Revolution CT scanners that could cause additional low-dose radiation exposure to patients. The first issue could delay the transition from monitoring to diagnostic scans during Smart Prep procedures, resulting in extra radiation. The second issue is scout images could become rotated if foot pedals instead of the gantry are used to reposition patients, requiring another scout. As a precaution, hospitals are advised to disable the Real-Time Systems function and only use gantry controls for repositioning until GE provides a correction. GE will remedy any defects without charge to ensure patient safety and compliance with federal standards. Hospitals should contact GE with any questions or concerns.

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    © All Rights Reserved
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    of 2

    GE Healthcare

    Important 3000 N. Grandview Blvd. - W440


    Waukesha, WI 53188, USA
    Electronic Product
    Radiation Warning

    < Date of Letter Deployment> GEHC Ref# 25487

    To: Hospital Administrators / Risk Managers


    Managers of Radiology/Cardiology
    Radiologist/Cardiologist
    Chairman Medical Board
    Relevant Head of Departments for hospital

    RE: GE Healthcare Revolution CT scan issues potentially causing additional low dose exposure

    Please ensure that all potential users in your facility are made aware of this notification and the
    recommended actions.

    Defect Description GE Healthcare has become aware of two potential issues on Revolution CT Scanners
    and Related that could cause additional low dose radiation exposure.
    Hazards
    The first issue could delay the transition from the monitor to diagnostic scan phase
    during a Smart Prep procedure. In this case, the system would acquire additional
    monitor scans and result in extra radiation delivered to the patient. In some cases,
    this may also necessitate a re-scan of the patient.

    The second issue is that scout images could become rotated if the foot pedals are
    used to reposition the patient instead of the gantry controls. This could mean
    another scout image must be acquired thereby delivering additional X-Ray radiation.

    Safety Instructions You can continue using your system.

    Recommended workaround instructions to use until the correction is provided:


    • To prevent a potential Smart Prep transition delay, the RTS (Real Time Systems)
    function should be disabled. This function collects system health related data
    but was found to interfere with the Smart Prep transition timing. Please contact
    your local Service Representative if you would like GE Healthcare to disable this
    function on your system.
    • When performing a scout scan use only the gantry controls to reposition the
    patient as indicated in the operator manual.

    Affected Product Revolution CT


    Details

    Product Correction GE Healthcare will, without charge, remedy the defect or bring the product into
    compliance with each applicable Federal standard in accordance with a plan to be
    approved by the Secretary of Health and Human Services, the details of which will be
    included in a subsequent communication to you or through a GE Healthcare field
    engineer site visit.

    Contact If you have any questions or concerns regarding this notification, please contact GE
    Information Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Page 1 of 2
    Please be assured that maintaining a high level of safety and quality is our highest priority. If you have
    any questions, please contact us immediately per the contact information above.

    Sincerely,

    James W. Dennison Jeff Hersh, PhD MD


    Vice President - Quality Assurance Chief Medical Officer
    GE Healthcare GE Healthcare

    Page 2 of 2

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