Ge Medical Systems Information T

Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.

FDA Recall

Terminated ·Ge Medical Systems Information T·Product code LLZ·February 18, 2013

Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.

FDA Enforcement

Class II ·Terminated·Ge Medical Systems Information T·April 19, 2017

INNOVA 4100-IQ

FDA Adverse Event

Death ·GE MEDICAL SYSTEMS SCS·Product code OWB·September 24, 2015

GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201

FDA Recall

Terminated ·GE Healthcare Clinical Systems·Product code IYN·September 4, 2007

Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.

FDA Recall

Terminated ·GE Healthcare, LLC·Product code LNH·May 11, 2009

GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.

FDA Recall

Terminated ·GE Medical Systems, LLC·Product code LNH·April 16, 2009

Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System

FDA Recall

Open, Classified ·GE Healthcare·Product code LLZ·March 28, 2023

SIGNA 0.7T OPENSPEED WITH EXCITE

FDA Adverse Event

Malfunction ·GE MEDICAL SYSTEMS, LLC.·Product code LNH·October 27, 2011

MIL VG HAWKEYE

FDA Adverse Event

Death ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·Product code KPS·December 18, 2015

9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, 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@ Infinity systems 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 Healthcare, LLC·Product code LNH·November 9, 2010

GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350), 1.5T SIGNA ECHOSPEED, 1.5T SIGNA EXCITE, 1.5T SIGNA EXCITE MRI, 1.5T SIGNA VIBRANT 16CH FIXED, 3.0T MRI TWINSPEED 8CH, 3.0T SIGNA EXCITE FIXED, 3.0T SIGNA EXCITE UPGRADE, 3T EXCITE, EX ES+8CH USED EXCITE, EXCITE 1.5T, EXCITE 3.0T, EXCITE TWIN, GOLDSEAL 1.5T EXCITE 4CH, GOLDSEAL 1.5T EXCITE 8CH, GOLDSEAL 1.5T EXCITE REL GOLDSEAL EXCITE 1.5T, GOLDSEAL EXCITE 1.5T 8CH, GS 1.5 EX ES+ 4CH NEW, GS 1.5 EX ES+4CH USED, GS 1.5 EX ES+8CH NEW, GS 1.5T EXCITE MRI, GS CLASS 1.5T ES+ EX 4CHN, GS SIGNA EXCITE II 1.5T, GS SIGNA MR/I 1.5T, LCC EXCITE 1.5T, MR 1.5 EX ES 8CH NEW, MR 1.5 EX ES+ 4CH, MR 1.5 EX ES+4CH MOB, MR 1.5 EX ES+8CH, MR 1.5EX8CH, MR 1.5EX8CH USE -HUNG, MR 1.5T EX8CH, MR 1.5T EXCITE 4CH, MR 1.5T EXCITE EXPERT MR, MR 1.5T EXCITE GS, MR 1.5T EXCITE GS MR, MR 1.5T GS ES+ EXCITE 4 CHANNE, MR 1.5T SIGNA EXCITE 8 CH GOLD SEAL, MR 1.5T SIGNA EXCITE II 4CH, MR 3.0T TWINSPEED, MR 3.0T SIGNA EXCI, MR 3.0T SIGNA EXCITE, MR 3.0T SIGNA EXCITE FIXED, MR EXCITE, MR EXCITE 1.5T, MR EXCITE 3, MR EXCITE ECHOSPEE, MR EXCITE ECHOSPEE UPG, MR EXCITE ECHOSPEED, MR EXCITE HISPEED MR EXCITE TWINSPEE, MR EXCITE TWINSPEED, MR GOLD SEAL 1.5 EX ES+8CH NEW, MR GOLDSEAL 1.5 ES PL EX 4 CH, MR GOLDSEAL 1.5 EX, MR GOLDSEAL 1.5 EX, MR GOLDSEAL 1.5 EX 4CH, MR GOLDSEAL 1.5 EX 8CH, MR GOLDSEAL 1.5 EX ES+ 4CH, MR GOLDSEAL 1.5 EX ES+ 4CH NEW, MR GOLDSEAL 1.5 EX ES+4CH, MR GOLDSEAL 1.5 EX ES+4CH USD, MR GOLDSEAL 1.5 EX ES+4CH USE, MR GOLDSEAL 1.5 EX ES+4CH USED, R GOLDSEAL 1.5 EX ES+8CH, MR GOLDSEAL 1.5 EX ES+8CH NEW, MR GOLDSEAL 1.5 EX ES+8CH USED, MR GOLDSEAL 1.5 EXCITE S+ 4CH, MR GOLDSEAL 1.5 FIXED ACTIVE, MR GOLDSEAL 1.5EX4CH NEW -HUNG, MR GOLDSEAL 3.0T EXCITE HD FIX, MR GS 1.5 EX, MR GS 1.5 EX ES+8C, MR GS 1.5 EX ES+8CH, MR SIGNA 1.5 EXCIT, MR SIGNA 1.5 EXCITE EXPERT, MR SIGNA 1.5T EXCITE, MR SIGNA 1.5T EXCITE 4CH MR SIGNA 1.5T EXCITE 8CH, MR SIGNA 1.5T EXCITE 8CH MOBIL, MR SIGNA 1.5T EXCITE EXPERT, MR SIGNA 1.5T EXCITE II, MR SIGNA 15T EXCITE 8CH, MR SIGNA 15T EXCITE 8CH MOBIL, MR SIGNA EXCITE 1.5 T GS (4 CHANNEL, MR SIGNA MR/I ECHOS W/EXCITE, MR SIGNA MR/I ECHOSPD W/ EXCITE, MR SIGNA MR/I ECHOSPD W/ EXCITE , MR SIGNA MR/I ECHOSPEED W/ EXCITE, MR SIGNA MR/I HISPEED W/ EXCITE MR SIGNA MR/I TWISP TR W/EXCIT, MR TWINSPEED 1.5T W/ EXCITE, MR UPG 1.5 SIGNA LX TO EXCITE, MR UPG 3.0T94 ECLIPSE TO EXCIT, MR/I ECHOSPD W/ EXCITE, MR/I ECHOSPEED W/ EXCITE, MR/I SIGNA ECHOSPD W/ EXCITE, MRI EXCITE, MRI EXCITE 1.5T FIXED, MRI SIGNA EXCITE 1.5T, PREOWN 1.5T EXITE, SIGNA 1.5 EXCITE, SIGNA 1.5T , CHOSPEED W EXCITE, SIGNA 1.5T ECHOSPEED W/EXCITE, SIGNA 1.5T ES EXCITE, SIGNA 1.5T EXCITE, SIGNA 1.5T EXCITE 2, SIGNA 1.5T EXCITE EXPERT, SIGNA 1.5T EXCITE II, SIGNA 1.5T SMART SPEED, /EXCITE, SIGNA 1.5T W/ EXCITE, SIGNA 3.0T E, SIGNA 3.0T SIGNA EXCITE FIXED, SIGNA ECHOSPEED 1.5T FIXED, SIGNA ECHOSPEED EXCITE 1.5T, SIGNA ECHOSPEED LX 1.5T FIXED SIGNA ECHOSPEED PLUS + EXCITE, SIGNA EXCITE, SIGNA EXCITE 1.5 SIGNA EXCITE 1.5 T HISPEED, SIGNA EXCITE 1.5T, SIGNA EXCITE 1.5T RELEASE 12.X/MR, SIGNA EXCITE 1.5T SMART SPEED, SIGNA EXCITE 11X, SIGNA EXCITE 3.0T, SIGNA EXCITE ECHOSPEED 1,5 T, SIGNA EXCITE ECHOSPEEED PLUS 1.5 T, SIGNA EXCITE EXPERT 1.5T, SIGNA EXCITE GS 1.5T 4 CHANNEL,SIGNA EXCITE II, SIGNA HISPD LX K4 1.5T FIXED, SIGNA HORIZON LX 1.5T FIXED, SIGNA LX 1.5 EXCITE II., SIGNA LX 1.5T EXCITE, SIGNA LX 1.5T EXCITE II, SIGNA LX1.5T HISPEED, SIGNA MR 1.5 ES EXCITE, SIGNA MR/I 1.5T EXCITE, SIGNA MR/I ECHO W/E,SIGNA MR/I ECHOESPEED W/EXCITE, SIGNA MR/I ECHOSPD, SIGNA MR/I ECHOSPD 1.5T FIXED, SIGNA MR/I ECHOSPD W/ EXCITE 1.5, SIGNA MR/I ECHOSPEED W/ EXCITE, SIGNA MR/I ECHOSPEED W/ EXCITE 1.5T, SIGNA MR/I ECHOSPEED W/EXCITE, SIGNA MR/I ECHOSPEED WITH EXCI, SIGNA MR/I ECHOSPEED WITH EXCITE SIGNA, MR/I

FDA Recall

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

GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP, 1.5 TWINSPEED HD 8CH-400-AP, MR UPGRADE LX/HZ TO HD FOR NON LCC, 1.5 TWINSPEED HD 16CH-800-AP, 1-5T HDXT TWINSPEED 16 CHANNEL, SIGNA MR/I TWISP TR W/EXCITE, 3T HD 16CH-800-AP, 1.5 ECHOSPEED HD 4-CH 200-AP, UPGRADE PREEXCITE TO 1.5TS HD 8CH, MR GOLDSEAL 1.5T HDXT 16CH NEW, MR GOLDSEAL 1.5T HD ES 8CH MOB, 1-5T NON LCC LX/5_5 TO HDIUPG8CH, UPGRADE 1.5 EXC-II TO EXC-III 16HD, UPGRADE 1.5 HORIZON TO HS/ES EXCITE, UPGRADE FROM 1.5 4X TO HISPEED LX, 1.5 LX TO HD 8CH FORKLIFT UPG., MR GOLDSEAL 1.5 LX HISP PL NEW, MR UPGRADE 4X/5X TO HD FOR NON LCC, MR GOLDSEAL 1.5 ES+ LX, SIGNA HISPEED LX 1.5T FIXED, 3T HD T/R W/EXCITE, 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA 1.5 ECHOSPEED HD 8-CH 400-A, SIGNA EXCITE HD 1.5T, MR EXCITE12X, MR GOLDSEAL 1.5T HD 8CH USE, 1.5T BRM ES 16CH 2 VRE FIXED F, UPG 1.5 EXC-II TO EXC-III HD, EXCITE HD - UPG 3.5 EXC, 1.5 ECHOSPEED HD 4-CH 200, SIGNA HD ADVANCED, EXCITE HD, 1.5 ECHOSPEED HD 16-CH, MR 1.5T HD, 1.5 ECHOSPEED HD 8-CH, MR 1.5 EXCITE HD, MR GOLDSEAL 1.5T HD ES 8CH NEW, 1.5T EXCITE HD, SIGNA ECHOSPD LX K4 1.5T FIXED, 1.5T LX TO 8CH HD 23 UPG, 1.5 HISPEED HD 8-C, SIGNA EXCITE 1.5T HD, MR 1.5T HD ECHOSPEED WITH EXCITE, MR 1.5T HD TWINSPE, MR 1.5T HD ECHOSPEED, MR SIGNA VH/I 3.0T, MR 3.0T HD 16CH, MR 1.5T HD TWINSPEED, MR 3.0T HD 8CH, MR UPG TO 1.5 HD, MR UPG TO 1.5T HD, MR UPG 1.5ES HD 8CH, SIGNA EXCITE HD 1.5 T, SIGNA EXCITE HD, SIGNA MR/I ECHOSPD 1.5T FIX(+75798), SIGNA ES EXCITE, SIGNA 1.5T ECHO HD, MR HD (VON FA. LINK), SIGNA 1.5T ECHOSPEED HD, SIGNA MR 1.5T ECHO HD, SIGNA EXITE-III HD, SIGNA 1.5T HD, ECHOSPEED HD 8-CH, 1.5 ECHOSPEED HD 8CH, MR 1.5T EXCITE HD, MR SIGNA EXCITE 3T HD, MR 1.5 ECHOSPEED HD 8-CH 400-AP, 1.5 ECHOSPEED HD, 1.5T HD, 1.5T HD PREOWN, 1.5T ECHO SPEED, 1.5 ECHOSPEED HD , SIGNA MR 1.5 ECHOSPEED 8CH, SIGNA HD 1.5 ES, MR ECHOSPEED 1.5 HD, SIGNA 1.5TECHOSPEED, MR 1.5 ECHOSPEED HD 8-CH, 1.5T HD EXCITE, SIGNA 1.5 T ECHOSPEED, SIGNA VH/I 3.0T, MR 1.5T HD 16CH, MR 1.5T HD 8CH USED, SIGNA EXCITE3 HD, MR SIGNA EXCITE HD (UPGR.), 1.5T EXCITE-HD, 1.5T EX-HD TWIN, SIGNA 3T, MR 1.5 ECHOSPEED HD 8-CH 400-A, 1.5T EXCITE HD GS, 3T E2, 1.5 ECHOSPEED HD 8-CH 400-, SIGNA EXCITE III HD 1.5T TWIN SPEED, MR GOLDSEAL 1.5T HD 16CH USED, EXCITE II UPG, SIGNA EXCITE III HD 3.0T, MR SIGNA EXCITE, 1.5T SIGNA EXCITE III HD, MR SIGNA HD, SIGNA EXCITE HD 1.5, 3T EXCITE HD, UPG PREEXCITE TO 1.5ES HD 8CH, MR SIGNA SMARTSPEED 1.5, 1.5T HD ECHOSPEED 8 CHANNEL, SIGNA 1.5 MOBILE EXCITE HD, SIGNA 3T HD 16CH-800-AP, SIGNA 3T HD 8CH-400-AP, 1.5T MRI EXCITE 3 UPGRADE, MR 1.5 ECHOSPEED HD 4-CH 200-AP, SIGNA 1.5 ECHOSPEED HD 8-CH 400-AP, SIGNA EXCITE 1.5T ECHOSPEED HD 4CH, MR 3T HD 8CH-400-AP, SIGNA 1.5T ECHOSPEED HD 4-CH 200-AP, 1.5 ECHOSPEED HD 16CH 800AP-2669585, 1.5 ECHOSPEED HD 8-CH 400-AP2669575, 1.5T ECHOSPEED HD16-CH800-AP2669583, UPG 1.5 EXC-II TO EXC-III HD-561936, 1.5 TWINSPEED HD 8CH-400-AP-2583394, 1.5 ECHOSPEED HD 8-CH 400-AP2700482, 1.5 ECHOSPEED HDMR, 1.5 ECHOSPEED HD 8-CH 400-AP EXCITE, MR 1.5 ECHOSPEED HD 8-C, MR SIGNA 1.5T HD 8CH, MR SIGNA 15T HD UPGRADED, MR SIGNA 3T HD 8CH-400-AP, MR SIGNA 1.5T HD UPGRADED, MR SIGNA 1.5T HD 8CH MOBIL, EXCITE HD 1.5T UPGRADES, MR SIGNA EXCITE HD 15T, MR SIGNA EXCITE HD 1.5T, MR 1.5 ECHOSPEED HD 16-CH, MR PROFILE HD PHASE ARRAY, SIGNA 3T EX HD, MR SIGNA VH/I 3.0, MR SIGNA MR/I HISPEED 1.5T, 1.5T ECHOSPEED HD, 1.5 ECHOSPEED HD 8, 1.5T ECHOSPEED HD 8, 1.5 T ECHOSPEED HD 4-CH 200-AP, SIGNA EXCITE 3T HD 8CH-400-AP, MR 1.5T ECHOSPEED HD 8-CH 400-AP, MR 1.5 ECHOSPEED HD 4-CH 200-A, MR/I 1.5 ECHOSPEED HD 4CH 200-, MR 15T ECHOSPEED HD 8-CH 400-, MR 15 ECHOSPEED HD 4-CH 200-A, MR 1.5 ECHOSPEED HD 8-CH 400-AP//, SIGNA 1.5T, SIGNA MR/I ECHOSPD W/ EXCIT, 1.5T EXCITE HD 16 CH, 1.5T HD E

FDA Recall

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

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

FDA Enforcement

Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025

Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 5481490-2, 5396469-3, 2394952-100, 5911000-3, 5373011-3); F. 3.0T MR750W GEM ENABLED PLU (5352293); G. 3.0T MR750W GEM ENABLED PLUS (5352293, 5499460-10); H. 3.0T MR750W W GEM (5352293, 5911000-3); I. 3.0T MR750W WITH GEM (5481490-2, 5911000-3); J. 3-0T MR750 32 CHANNEL (5352293); K. 3-0T MR750W FUTURE GEM CAPABLE (5352293, 5911000-3, 5499460-7); L. 3-0T MR750W GEM (5495558, 5352293); M. 3-0T MR750W GEM ENABLED (5911000-3, 5352293, 2394952-100, 5481490-2, 5499460-7, 5373011-3, 5495558, 5481490, 5396469-3, 5481490-3); N. 3-0T MR750W GEM ENABLED PLUS (5911000-3, 5352293, 5499460-10, 5481490-2); O. 3-0T MR750W NON GEM (5911000-3); P. 3T 750W (5921000-2, 5911000-3, 5396469-3, 5352293, 5481490-2, 5481490-3); Q. DISCOVERY MR 750W 3.0T (5481490-2, 5911000-3, 5499460-10); R. DISCOVERY MR750W (5911000-3); S. DISCOVERY MR750W 3 (5481490-2, 5911000-3); T. DISCOVERY MR750W 3T (5911000-3, 5396469-3, 5373011-3, 5481490-2); U. DISCOVERY MR750W GEM (5396469-3, 5352293); V. DISCOVERY MR750W WITH GEM (5911000-3); W. MR 3.0T MR750 W (5352293); X. MR 3.0T MR750W GEM ENABLED (5911000-3, 5352293); Y. MR 3-0T MR750W (5911000-3); Z. MR DISCOVERY 750W GEM (5911000-3); AA. MR OPTIMA MR750W 3.0T (5911000-3); BB. MR750W (5911000-3); CC. MR750W GEM ENABLED (5911000-3, 5499460-7); DD. MR750W GEM ENABLED PLUS (5352293); EE. MR750W PGR 32-CHANNEL (5911000-3); FF. 3.0T MR750W GEM ENAB (5911000-3) Product Usage: The Discovery MR750w 3.0T system is 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 Discovery MR750w 3.0T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance..

FDA Recall

Terminated ·GE Medical Systems, LLC·Product code LNH·June 6, 2018

Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.

FDA Recall

Terminated ·Westmed, Inc.·Product code BYE·January 15, 2019

Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.

FDA Recall

Terminated ·Westmed, Inc.·Product code BYE·January 15, 2019

Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.

FDA Recall

Terminated ·Westmed, Inc.·Product code BYE·January 15, 2019

GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: ER15T HDXT ECHOSPEED 16 CHANNEL, OC1.5T HDX ECHOSPEED 8 CHANNEL, SC1.5T HD TO HDX UPGRADE, TR15T HDXT 16CH, TR3.0T 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

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment to record EGG signals from surface electrodes. The basic system shall provide 2 modes of operation: (I) Resting EGG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of EGG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.

FDA Recall

Terminated ·GE Medical Systems, LLC·Product code DPS·December 10, 2009