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    GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX UPGRADE, 1.5 HDX, 1.5 HDX ECHOSPEED 16 CH, 1.5 HDX ECHOSPEED 8 CHANNEL, 1.5 HDXT, 1.5 HDXT-16 , 1.5 LX TO HDX 16C FORKLIFT UPG, 1.5 LX TO HDX 8C FORKLIFT UPG, 1.5 T UPGRADE TO HDX, 1.5EXCIT TO HDXT UPG, 1.5T HDX 16 CHANNEL, 1.5T 16CH UPG, 1.5T 6 CH HDX , UPGRADE, 1.5T 8CH HDXT TO 16CH HDXT UPG, 1.5T CRM LX TO HDX UPG, 1.5T ES HDX W/ONCOLOGY PACK, 1.5T EXC.TO HDX UPG, 1.5T EXC.TO HDXT UPG, 1.5T EXCITE HD TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG. W/ACGD, 1.5T EXCITE TO HDXT UPG, 1.5T EXCITE TO HDXT UPGRADE, 1.5T EX-HDX, 1.5T EX-HDXTWIN, 1.5T HD ES/HS MOBILE, 1.5T HD TO HDX UPG. 1.5T HD TO HDX UPGRADE, 1.5T HD TO HDXT UPG, 1.5T HD TO HDXT UPGRADE 1.5T HDI,1.5T HDI 16CH FIXED, 1.5T HDI 8CH FIXED, 1.5T HDI ECHOSPEED 1.5T HDI ECHOSPEED 8 CHANNEL, 1.5T HDI ECHOSPEED 8 CHANNEL 1.5T HDI ECHOSPEED 8 CHANNEL., 1.5T HDI ECHOSPEED 8 CHANNEL, 1.5T HDI ECHOSPEED 8 CHANSO2762285, 1.5T HDI ECHOSPEED 8CH, 1.5T HDI ECHOSPEED MOBILE, 1.5T HDI ECSHOSPEED 8CH, 1.5T HDI TO HDXT UPGRADE, 1.5T HDX, 1.5T HDX - MEIRAV (BREAST), 1.5T HDX 8CM 1.5T HDX ECHOSPD 16, 1.5T HDX ECHOSPEED, 1.5T HDX ECHOSPEED 1.5T HDX ECHOSPEED 16, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNELS, 1.5T HDX ECHOSPEED 16CHSO2659508, 1.5T HDX ECHOSPEED 16CH-SO2718893, 1.5T HDX ECHOSPEED 32 CHANNEL, 1.5T HDX ECHOSPEED 8 CH, 1.5T HDX ECHOSPEED 8 CHANNEL, 1.5T HDX ECHOSPEED MOBILE 1.5T HDX ECHOSPEED MRI, 1.5T HDX ES, 1.5T HDX ES 16, 1.5T HDX TWINSPEED, 1.5T HDX TWINSPEED 16 CHANNEL, 1.5T HDXT 1.5T HDXT 16CH,1.5T HDXT 16CH CXK4, 1.5T HDXT 16CH ES FIXED 1.5T HDXT 8 CH, 1.5T HDXT 8CH ES FIXED, 1.5T HDXT 8CH UP, 1.5T HDXT ECHOSPEE, 1.5T HDXT ECHOSPEED, 1.5T HDXT ECHOSPEED 16 CH 1.5T HDXT ECHOSPEED 16 CHAN, 1.5T HDXT ECHOSPEED 16 CHANNEL 1.5T HDXT ECHOSPEED 8, 1.5T HDXT ECHOSPEED 8 CHANN, 1.5T HDXT ECHOSPEED 8 CHANNEL, 1.5T HDXT ECHOSPEED 8 CHANNEL , 1.5T HDXT ECHOSPEED 8_CHANNEL, 1.5T HDXT ECHOSPEED MOBILE, 1.5T HDXT ES 8 CH, 1.5T HDXT GS, 1.5T HDXT TWIN, 1.5T HDXT TWINSPEE, 1.5T HDXT TWINSPEED 16 CHAN,1.5T HDXT UPG, 1.5T HDXTID, 1.5T LX HDX, 1.5T LX TO 16 CH HDXT UPG, 1.5T LX TO 16 CHAN, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPGRADE, 1.5T LX TO 16 CHANNEL HDXT, 1.5T LX TO 16 CHANNEL HDXT UPG, 1.5T LX TO 16CHANNEL HDX U/G2777896, 1.5T LX TO 8 CH HDX UPG, 1.5T LX TO 8 CH HDXT UPG, 1.5T LX TO 8 CHANNEL HDX UP, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG.827015, 1.5T LX TO 8 CHANNEL HDXT UPG, 1.5T LX TO 8 CHANNEL HDXT UPGRADE, 1.5T LX TO HDXT 1.5T NON LCC4X5X TO HDXT UPGD, 1.5T NON-LCC LX/HRZ 5.5 TO 1.5T HDX, 1.5T SIGNA HDX UPG, 1.5T SIGNA HDXT, 1.5TEXCITE TO HDX UPG W/O A, 1.5TEXCITE TO HDX UPG W/O ACGD, 1.5TNONLCC LXHZ TO HDXT UPG, 1.5TNONLCC LXHZ TO HDXUPGW/ACD, 1.5TNONLCC4X5X TO HDXUPGW/OACD, 1.5TNONLCCLXHZ TO HDXUPGW/O ACD, 15T 8CH HDXT MRI, 15T HDXT, 15T HDXT MRI, 1-5T CRM LX TO HDX , G.W/OACGD, 1-5T CRM LX TO HDXT UPG, 1-5T EXCITE TO 15T EXCITE TO HDX UPG, 1-5T HDI ECHOSPEED 16 CHANNEL, 15T HDI ECHOSPEED 8 CHANNEL, 1-5T HDX ECHOSPEED 16 CHANN, 15T HDX ECHOSPEED 16 CHANNEL, 15T HDX ECHOSPEED 8 CHANNEL, 15T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED TRANSPORT, 1-5T HDX TWINSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED 16, 1-5T HDXT ECHOSPEED 16 CHAN, 1-5T HDXT ECHOSPEED 16 CHAN-HD16.0, 1-5T HDXT ECHOSPEED 16 CHANNEL, 1-5T HDXT ECHOSPEED 16 CHANNEL, 1-5T HDXT ECHOSPEED 16 UPGRADE, 1-5T HDXT ECHOSPEED 8 CHANN, 15T HDXT ECHOSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED MOBILE, 1-5T HDXT ECHOSPEED RELOCATABLE, 1-5T LX TO 16 CHANNEL HDX UPG, 1-5T LX TO 16 CHANNEL HDXT, 1-5T LX TO 8 CHANNEL HDXT U, 1-5T LX TO

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·June 7, 2018

    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

    FDA Enforcement
    Class I ·Terminated·Acist Medical Systems·March 10, 2021

    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code OBJ·January 22, 2021

    GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX UPGRADE, 1.5 HDX, 1.5 HDX ECHOSPEED 16 CH, 1.5 HDX ECHOSPEED 8 CHANNEL, 1.5 HDXT, 1.5 HDXT-16 , 1.5 LX TO HDX 16C FORKLIFT UPG, 1.5 LX TO HDX 8C FORKLIFT UPG, 1.5 T UPGRADE TO HDX, 1.5EXCIT TO HDXT UPG, 1.5T HDX 16 CHANNEL, 1.5T 16CH UPG, 1.5T 6 CH HDX , UPGRADE, 1.5T 8CH HDXT TO 16CH HDXT UPG, 1.5T CRM LX TO HDX UPG, 1.5T ES HDX W/ONCOLOGY PACK, 1.5T EXC.TO HDX UPG, 1.5T EXC.TO HDXT UPG, 1.5T EXCITE HD TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG. W/ACGD, 1.5T EXCITE TO HDXT UPG, 1.5T EXCITE TO HDXT UPGRADE, 1.5T EX-HDX, 1.5T EX-HDXTWIN, 1.5T HD ES/HS MOBILE, 1.5T HD TO HDX UPG. 1.5T HD TO HDX UPGRADE, 1.5T HD TO HDXT UPG, 1.5T HD TO HDXT UPGRADE 1.5T HDI,1.5T HDI 16CH FIXED, 1.5T HDI 8CH FIXED, 1.5T HDI ECHOSPEED 1.5T HDI ECHOSPEED 8 CHANNEL, 1.5T HDI ECHOSPEED 8 CHANNEL 1.5T HDI ECHOSPEED 8 CHANNEL., 1.5T HDI ECHOSPEED 8 CHANNEL, 1.5T HDI ECHOSPEED 8 CHAN¿SO2762285, 1.5T HDI ECHOSPEED 8CH, 1.5T HDI ECHOSPEED MOBILE, 1.5T HDI ECSHOSPEED 8CH, 1.5T HDI TO HDXT UPGRADE, 1.5T HDX, 1.5T HDX - MEIRAV (BREAST), 1.5T HDX 8CM 1.5T HDX ECHOSPD 16, 1.5T HDX ECHOSPEED, 1.5T HDX ECHOSPEED 1.5T HDX ECHOSPEED 16, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNELS, 1.5T HDX ECHOSPEED 16CH¿SO2659508, 1.5T HDX ECHOSPEED 16CH-SO2718893, 1.5T HDX ECHOSPEED 32 CHANNEL, 1.5T HDX ECHOSPEED 8 CH, 1.5T HDX ECHOSPEED 8 CHANNEL, 1.5T HDX ECHOSPEED MOBILE 1.5T HDX ECHOSPEED MRI, 1.5T HDX ES, 1.5T HDX ES 16, 1.5T HDX TWINSPEED, 1.5T HDX TWINSPEED 16 CHANNEL, 1.5T HDXT 1.5T HDXT 16CH,1.5T HDXT 16CH CXK4, 1.5T HDXT 16CH ES FIXED 1.5T HDXT 8 CH, 1.5T HDXT 8CH ES FIXED, 1.5T HDXT 8CH UP, 1.5T HDXT ECHOSPEE, 1.5T HDXT ECHOSPEED, 1.5T HDXT ECHOSPEED 16 CH 1.5T HDXT ECHOSPEED 16 CHAN, 1.5T HDXT ECHOSPEED 16 CHANNEL 1.5T HDXT ECHOSPEED 8, 1.5T HDXT ECHOSPEED 8 CHANN, 1.5T HDXT ECHOSPEED 8 CHANNEL, 1.5T HDXT ECHOSPEED 8 CHANNEL , 1.5T HDXT ECHOSPEED 8_CHANNEL, 1.5T HDXT ECHOSPEED MOBILE, 1.5T HDXT ES 8 CH, 1.5T HDXT GS, 1.5T HDXT TWIN, 1.5T HDXT TWINSPEE, 1.5T HDXT TWINSPEED 16 CHAN,1.5T HDXT UPG, 1.5T HDXTID, 1.5T LX HDX, 1.5T LX TO 16 CH HDXT UPG, 1.5T LX TO 16 CHAN, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPGRADE, 1.5T LX TO 16 CHANNEL HDXT, 1.5T LX TO 16 CHANNEL HDXT UPG, 1.5T LX TO 16CHANNEL HDX U/G2777896, 1.5T LX TO 8 CH HDX UPG, 1.5T LX TO 8 CH HDXT UPG, 1.5T LX TO 8 CHANNEL HDX UP, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG.827015, 1.5T LX TO 8 CHANNEL HDXT UPG, 1.5T LX TO 8 CHANNEL HDXT UPGRADE, 1.5T LX TO HDXT 1.5T NON LCC4X5X TO HDXT UPGD, 1.5T NON-LCC LX/HRZ 5.5 TO 1.5T HDX, 1.5T SIGNA HDX UPG, 1.5T SIGNA HDXT, 1.5TEXCITE TO HDX UPG W/O A, 1.5TEXCITE TO HDX UPG W/O ACGD, 1.5TNONLCC LXHZ TO HDXT UPG, 1.5TNONLCC LXHZ TO HDXUPGW/ACD, 1.5TNONLCC4X5X TO HDXUPGW/OACD, 1.5TNONLCCLXHZ TO HDXUPGW/O ACD, 1¿5T 8CH HDXT MRI, 1¿5T HDXT, 1¿5T HDXT MRI, 1-5T CRM LX TO HDX , G.W/OACGD, 1-5T CRM LX TO HDXT UPG, 1-5T EXCITE TO 15T EXCITE TO HDX UPG, 1-5T HDI ECHOSPEED 16 CHANNEL, 15T HDI ECHOSPEED 8 CHANNEL, 1-5T HDX ECHOSPEED 16 CHANN, 15T HDX ECHOSPEED 16 CHANNEL, 15T HDX ECHOSPEED 8 CHANNEL, 15T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED TRANSPORT, 1-5T HDX TWINSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED 16, 1-5T HDXT ECHOSPEED 16 CHAN, 1-5T HDXT ECHOSPEED 16 CHAN-HD16.0, 1-5T HDXT ECHOSPEED 16 CHANNEL, 1-5T HDXT ECHOSPEED 16 CHANNEL, 1-5T HDXT ECHOSPEED 16 UPGRADE, 1-5T HDXT ECHOSPEED 8 CHANN, 15T HDXT ECHOSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED MOBILE, 1-5T HDXT ECHOSPEED RELOCATABLE, 1-5T LX TO 16 CHANNEL HDX UPG, 1-5T LX TO 16 CHANNEL HDXT, 1-5T LX TO 8 CHANNEL HDXT U, 1-5T LX TO

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·October 24, 2018

    HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).

    FDA Recall
    Terminated ·Philips Ultrasound, Inc.·Product code IYN·September 10, 2004

    Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Product also marketed as Philips 4000 New Standard, Philips 4000 System and Multibeam System. According to the firm, these units have the same user manual as the HDI4000 system. The different names are used internally as a description for the different configurations of model HDI 4000. Over the product lifecycle, the product configuration changed as follows: MULTIBEAM SYSTEM : This was the original HDI 4000 system branded with the former company name 'ATL' and labeled, "Distributed by ATL Ultrasound Bothell, WA. USA 98041"; PHILIPS 4000 SYSTEM :This configuration changed the legacy 'ATL' brand / colors to the 'Philips' brand / colors; PHILIPS 4000 NEW STANDARD: This Philips brand configuration eliminated hardware that supported the 'CV'. The CV option was initially standard, but later became optional depending on customer preference. The product ID label is the same for both PHILIPS 4000 SYSTEM and PHILIPS 4000 NEW STANDARD. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code IYN·August 12, 2008

    Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)

    FDA Recall
    Terminated ·Philips Ultrasound, Inc.·Product code DPW·May 6, 2005

    MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i (integrated) and MX 15 HDi. Long range surveillance, target designation.

    FDA Recall
    Terminated ·Wescam Inc 649 North Service Road West Burlington Canada Ontario·Product code RET·August 1, 2009

    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 Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 5, 2020

    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 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 Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 8, 2013

    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

    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

    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

    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 Enforcement
    Class II ·Terminated·GE Healthcare, LLC·March 20, 2013

    1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿ HDx MR system is 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. The images produced by the Signa eHDx system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·August 23, 2017

    1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: 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. The images produced by the 1.5T Signa HDx family and 3.0T Signa HDx family reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·August 23, 2017

    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 Enforcement
    Class II ·Terminated·GE Healthcare·August 12, 2015

    1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDx MR system is 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. The images produced by the Signa eHDx system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·May 11, 2017

    1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: 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. The images produced by the 1.5T Signa HDx family and 3.0T Signa HDx family reflects the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·May 11, 2017