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    GE OEC Medical Systems, Inc.

    Manufacturer
    🇺🇸 United States

    GE OEC MEDICAL SYSTEMS, INC

    FDA registration
    GE OEC MEDICAL SYSTEMS, INC·4 products·🇺🇸 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

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·October 22, 2007

    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

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 15, 2007

    9600+

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·January 22, 2008

    GE Medical Systems SCS

    Authorized representative
    🇫🇷 France·27 Manufacturers·564 Devices

    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

    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·March 22, 2017

    OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·July 25, 2012

    OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    FLUOROSTAR

    FDA Adverse Event
    Injury ·GE OEC MEDICAL SYSTEMS GMBH 14 WILHELM-MAISEL-STR·Product code OWB·March 29, 2021

    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·February 21, 2017