BEUDAMED
    159 results · 13ms · Sources: EU EUDAMED, US FDA

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    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·September 15, 2014

    Uroview 2600 Uroview System

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·May 12, 2003

    The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OWB·March 31, 2014

    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

    MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·March 28, 2006

    OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System,

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

    GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·March 23, 2007

    OEC 9900 Elite MD Motorized C-Arm System, 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

    GEHC OEC 9800 ESP-15 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

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

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

    OEC 9900 Elite 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

    OEC 9800 Plus Fluoroscopic X-ray System,

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

    GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·February 6, 2006

    OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended 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 Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code LLZ·June 22, 2009

    GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·October 19, 2007

    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

    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 Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·May 22, 2014

    OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·June 10, 2021