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    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·May 10, 2011

    Discovery XR656 HD. X-Ray imaging system.

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code KPR·January 28, 2025

    Optima XR646 HD. X-Ray imaging system.

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code KPR·January 28, 2025

    Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020

    FDA Recall
    Terminated ·Den-Tal-Ez Inc, Star Dental Div·May 16, 2003

    Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems contain the PURE software option.) Excite MR system is indicated for use as a diagnostic imaging device to produce images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·October 6, 2009

    GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. Indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.

    FDA Recall
    Terminated ·GE Healthcare·Product code LNH·October 1, 2007

    GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance imaging systems.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·December 23, 2021

    1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the Trilogy Radiotherapy Delivery System.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code IYE·March 17, 2011

    Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code IYE·June 23, 2010

    GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·April 9, 2013

    GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the internal structure or organs of the entire body,

    FDA Recall
    Terminated ·GE Healthcare·Product code LNH·March 28, 2008

    GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·June 8, 2012

    GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body.

    FDA Recall
    Terminated ·GE Healthcare·Product code LNH·December 14, 2007

    SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·December 23, 2019

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 31, 2011

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Recall
    Terminated ·GE Healthcare·Product code LNH·March 9, 2015

    GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi. Whole body magnetic resonance diagnostic imaging scanners.

    FDA Recall
    Terminated ·GE Healthcare·Product code LNH·July 10, 2015

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·June 2, 2016

    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·June 2, 2016