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    Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China

    FDA Recall
    Terminated ·GE Healthcare·Product code LNH·December 31, 2006

    VIVID S70N

    FDA Adverse Event
    Malfunction ·GE VINGMED ULTRASOUND AS·Product code IYN·January 5, 2023

    GE OEC Medical Systems, Inc.

    Manufacturer
    🇺🇸 United States

    InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·December 25, 2013

    GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·September 13, 2006

    GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·August 16, 2006

    GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·August 16, 2006

    OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·September 30, 2006

    GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·November 26, 2013

    Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·February 24, 2011

    Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·February 24, 2011

    PENTAX

    FDA Adverse Event
    Malfunction ·Product code FDF·December 23, 2019

    PENTAX

    FDA Adverse Event
    Malfunction ·Product code FDF·December 23, 2019

    OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System,

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007

    OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007

    ENTrak Plus Navigation and Visualization System

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·July 12, 2004

    GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·July 6, 2007

    GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·June 12, 2007

    OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·March 1, 2007