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Manufacturers
GE Healthcare Australia Pty Ltd
제조사 모회사 (2017)
General Electric Company
Source
DHTGA
131 Events
Proteus XR/a X-ray Imaging Systems 의 리콜
Innova 2121IQ and Innova 3131IQ Cardiovascular X-Ray Imaging Systems (diagnostic fluoroscopic angiography x-ray system) 의 리콜
Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient monitor). 의 리콜
Carescape Monitor B650 (Multi parameter patient monitor) 의 리콜
Carescape Monitor B850, all software versions (mutliparameter patient monitor) 의 리콜
Vital Signs Disposable General Purpose 9 French Temperature probes 의 리콜
Table pallet for use with Discovery NM/CT 670 & Discovery NM630 (Diagnostic full body CT X-ray system) 의 리콜
GE Corometrics Qwik Connect Plus Spiral Electrodes (single use electrodes used for electrocardiographs) 의 리콜
Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers (infant radiant warmer) 의 리콜
Monitors B20 or B40 Software version VSP-A_1.10 (or earlier) (Multiparameter Patient Monitor) 의 리콜
OEC 6800 MiniView C-arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray system) 의 리콜
FlexiView 8800 Mobile C-Arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray system) 의 리콜
Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control SystemManufactured between August 1 2012 and December 20 2012 의 리콜
Ventri and Discovery NM 530c (Full body computed tomography (CT) system) 의 리콜
Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000/4000/5000) 의 리콜
Advantx, Innova 2000, Innova 2100 IQ, Innova 3100, Innova 3100 IQ, Innova 4100, Innova 4100 IQ Cardiovascular X-ray Imaging Systems equipped with Video monitor Suspension model numbers 2236709, 2353620, 2223039-2 and 2270677-2 의 리콜
Avance CS2 Anesthesia Carestation 의 리콜
DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and September 2012 의 리콜
Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with certain PACS systems) 의 리콜
Optima MR430s and MSK 1.5T Extreme (MRI System) 의 리콜
1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant MR Systems (Magnetic Resonance Imaging Systems) 의 리콜
LOGIQ S8 with software revisions R1.1.1 and R1.5.1, and LOGIQ S7 with software revisions R1.0.1, R1.0.2 and R1.0.3 (Diagnostic ultrasound system) 의 리콜
Discovery MR450, MR750, MR750w and Optima MR450w products, running software versions DV22.0_V02, DV22.1_V01, DV23.0_V01 (MRI System) 의 리콜
Carbon dioxide absorbent canister for use with the Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 anaesthesia systems 의 리콜
PET VCAR Application Software (installed on Advantage Workstation and AW Server versions: Advantage Workstation 4.6, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 ) 의 리콜
Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, manufactured from 2003-2013VG and VG Hawkeye nuclear medicine systems, manufactured from 1996-2003 Helix nuclear medicine systems, manufactured from 1992-1996 (by Elscint Ltd) 의 리콜
GEHC Discovery NM/CT 670 Nuclear Medicine System 의 리콜
Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670All manufacturing dates 의 리콜
Disposable Breathing Circuit Kit 의 리콜
General Purpose 9 French Temperature Probe, Disposable, 400 의 리콜
ViewPoint 6 Versions 6.2, 6.2.1, 6.3 and 6.31 including OB Pro-Expert Reporting (Ultrasound image management software) 의 리콜
Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001) 의 리콜
Centricity PACS RA1000 Workstation (Picture Archiving and Communication System) 의 리콜
Discovery MR450, MR750 and Optima MR450w MRI System 의 리콜
Advantx, Innova 2000, Innova 2100 IQ, Innova 3100, Innova 3100 IQ, Innova 4100, Innova 4100 IQ Cardiovascular X-ray imaging systems equipped with Video Monitor Suspension (Fluoroscopic, angiographic x-ray system) 의 리콜
Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 April 2013 to 22 July 2013 의 리콜
B20, B30, B40 Patient Monitors (used for ECG monitoring) 의 리콜
Avance, Amingo, Aisys Anaesthesia Devices (software version 8.00) and Avance CS Anaesthesia Devices (with software version 10.00) 의 리콜
Discovery NM/CT 670, Optima NM/CT 640, Discovery NM630 and Brivo NM615 (all configurations) (Nuclear Medicine System) 의 리콜
GSI Viewer, prior to version 2.00-0M on AW and prior to version 2.20-0B in AW Server (Picture archiving and communication system, PACS) 의 리콜
Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations) 의 리콜
Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system) 의 리콜
CARESCAPE Monitor B850 (with software versions 1.0.12 and earlier) and CARESCAPE Monitor B650 (with software version 1.1.12 and earlier) 의 리콜
PDM module with Frame F5-01 used with CARESCAPE Monitor B850 의 리콜
Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module) 의 리콜
Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLab (Multifunction patient monitoring)All PDMs produced from April 2007 through June 2010 의 리콜
PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44 의 리콜
Giraffe Stand Alone Resuscitation Systems with Blender, Giraffe Warmer Integrated Resuscitation systems with Blender, Panda Warmer Integrated Resuscitation systems with Blender, Panda Freestanding Warmer Integrated Resuscitation systems with Blender and Resuscitation System field upgrade kits with Blender (infant radiant warmers) 의 리콜
Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII (diagnostic fluoroscopic x-ray systems) 의 리콜
Optima XR 220amx, Optima XR200amx with Digital Upgrade Mobile X-ray Systems 의 리콜
Giraffe Stand Alone Resuscitation Systems with Blender, Giraffe Warmer Integrated Resuscitation systems with Blender, Panda Warmer Integrated Resuscitation systems with Blender, Panda Freestanding Warmer Integrated Resuscitation Systems with Blender, Resuscitation System field upgrade kits with Blender 의 리콜
PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity.53 (Nuclear medicine diagnostic system) 의 리콜
Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor 의 리콜
Innova 3100, Innova 3100IQ and Innova 2100IQ Cardiovascular X-ray Imaging Systems 의 리콜
Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function patient monitor) 의 리콜
Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic x-ray system) 의 리콜
Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All configurations 의 리콜
Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors 의 리콜
INNOVA 2121IQ (Cardiovascular X-ray imaging system) 의 리콜
Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products (Full body magnetic resonance imaging systems) 의 리콜
OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems manufactured between October 9, 2013 and March 20, 2014, and all OEC 9900 systems that had an extension arm replaced between October 9, 2013 and March 20, 2014 are affected. 의 리콜
Kenex suspension arm with radiation shield and/or surgical lamp 의 리콜
Vivid E9 Ultrasound Systems, software versions 113.0.1 to 113.0.5 when used with probes C1-5-D, C2-9-D, IC-5-9-D and M5Sc-DARTG Number: 146317 의 리콜
Panda iRes Warmers integrated with Nellcor SpO2 의 리콜
Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w and Discovery MR750w equipped with the GEM option products (Full body magnetic resonance imaging (MRI) systems) 의 리콜
Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV & E-CAiOVX (used with CARESCAPE Monitors B850 and B650, Avance and Aisys Anesthesia Carestations, Engstrom Respiratory Carestation, or S/5 Anesthesia and Critical Care Monitors) 의 리콜
Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCREC (used with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Engstrom Carestation, Patient Monitor B30, S/5M and FML monitors) 의 리콜
CARESCAPE Monitor B650 Software Versions: 1.1.12.26 or earlier 의 리콜
Single-width Airway Module E-miniC and Extension Modules N-FC & N-FCRECAll units serviced with Field Replaceable Unit catalogue number M1013204 between February 2012 and May 2014. 의 리콜
Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systems 의 리콜
CARESCAPE Monitor B850, B650 or B450 Monitors with V2 software versions (Multiparameter patient monitors) 의 리콜
CARESCAPE respiratory modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE & the Airway Gas Option N-CAiO 의 리콜
Discovery XR656 Wall Stand System (X-ray system) 의 리콜
Patient Data Module (PDM) Used with CARESCAPE Monitor B850, B650, or B450 (Multiparameter Patient Monitor) 의 리콜
Multiple Models of GE Nuclear Medicine Systems:All VG and VG Hawkeye nuclear medicine systems, manufactured from 1996 - 2003: - Millennium VG - Millennium VG and Hawkeye- Discovery VH - VaricamAll Infinia nuclear medicine systems, manufactured from 2003 – 2014:- Infinia - Infinia and Hawkeye - Infinia and Hawkeye 4 All Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems. 의 리콜
Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (MRI System) 의 리콜
OEC 9800, OEC UroView 2800, OEC MiniView 6800, OEC FlexiView 8800 (mobile flouroscopic x-ray diagnostic system)Systems supplied in Australia:System: OEC 9800 의 리콜
Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators 의 리콜
Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order) 의 리콜
GE Healthcare MRI systems with superconducting magnets 의 리콜
Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354. 의 리콜
T2100 and T2000 Treadmill power cords 의 리콜
Kenex ceiling-suspended radiation shields and surgical lamps 의 리콜
T2100 Treadmill 의 리콜
GE MRI SystemsDiscovery MR450/MR750/ MR750W GEM, Optima MR360/ MR450w/MR450w GEM/ MR950, Brivo MR355, Twinspeed, Vectra, MR Max, Signa HDx/HDxt/HDi/ 1.5T HDe/Excite-HD 1.5T & 3T/ Excite 1.5T HD, Echospeed & Highspeed/ 1.5T Infinity TwinSpeed, EchoSpeed Plus & HiSpeed Plus/1.0T Infinity HiSpeed Plus & SmartSpeed/EXCITE 3.0T/ EXCITE 3.0T HD/ Excite 1.5T TwinSpeed & EchoSpeed, HiSpeed & SmartSpeed/ Excite 1.5T/ Excite 3.0T/ Contour/I / OpenSpeed/ Profile /Ovation / PET/MR 의 리콜
D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors (used in Anaesthesia and Critical Care areas) 의 리콜
All Precision 500D Radiographic and Fluoroscopic (R&F;) Systems and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic (R&F;) Systems 의 리콜
Single and dual LCD monitor suspensions used on Precision RXi fluoroscopic imaging systems 의 리콜
MR ACGD Cabinet FRU X Gradient Cable used with GE MRI System Affected Systems: Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite 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. 의 리콜
GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Power Supply (part number 2334455) 의 리콜
GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR 3.0T,SIGNA HDxt 3.0T, SIGNA HDx 3.0T, SIGNA HD 3.0T, SIGNA Excite 3.0T and SIGNA 3.0T 의 리콜
Giraffe Shuttle Products (uninterruptable power supply for Giraffe Products) 의 리콜
Vital Signs LightWand Stylet 의 리콜
Revolution CT Scanners, software version 15MW03.12 의 리콜
All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015 의 리콜
Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems 의 리콜
Mavig Monitor suspension arms manufactured before January 2009 (used with x-ray fluoroscopic imaging systems) Installed on INNOVA 2100, 3100 fluoroscopic imaging systems. 의 리콜
Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 Anesthesia devices installed from April 20, 2015 through October 2015. Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected 의 리콜
Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits 의 리콜
PRN 50-M+ Digital Writer 의 리콜
3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures) 의 리콜
SIGNA Pioneer MRI System 의 리콜
Aisys CS2 and upgraded Aisys anaesthesia devices (with software version 10.X) 의 리콜
Aisys and Aisys CS2 Anaesthesia machines with the optional Vacuum Suction Function 의 리콜
Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diagnostic systems) 의 리콜
GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016 의 리콜
MSK 1.5T Extreme and Optima MR430s (MRI Systems) 의 리콜
Revolution CT (diagnostic x-ray system) 의 리콜
Discovery MR750w (MRI System) 의 리콜
Infant Warmer System (IWS) 의 리콜
SIGNA Creator and SIGNA Explorer (MRI System) 의 리콜
MAGiC (MAGnetic resonance image Compilation) on Signa Pioneer MRI systems running application software version DV25.1 의 리콜
Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory installed 의 리콜
Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy and Precision 500D, ADVANTX and Innova 2000 Systems(Diagnostic fluoroscopic x-ray systems) 의 리콜
Advantx Legacy/Legacy-D Radiographic and Fluoroscopic System 의 리콜
Multiple Vivid Ultrasound Products Vivid E95/E90/E80 with software version 201, revision 54.0 and 61.0 Vivid S70/S60 with software version 201, revision 55.0 and 63.0Vivid S70N/S60N with software version 201, revision 63.0 의 리콜
Carestation 620, 650 and 650c A1 Anaesthesia devices Carestation 의 리콜
OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017 의 리콜
CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 and B450 with v2.0.7 or earlier software) 의 리콜
3.0T GE 6-Channel Phased Array Flex Coil 의 리콜
All Carestation 620, 650 and 650c Anaesthesia systems 의 리콜
Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe OmniBed, Giraffe Warmer, Panda Warmer, Giraffe Incubator, Care Plus Incubator, IWS, and Giraffe Shuttle. 의 리콜
CARESCAPE R860 ventilators with software version 10SP05 의 리콜
CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one 의 리콜
Use of Tristel Trio Wipes System with GE TEE probe 의 리콜
Discovery IGS 730 의 리콜
Vivid and LOGIQ Ultrasound Systems 의 리콜
GE Healthcare Revolution EVO & Optima CT Systems CT660, CT670, CT680, CT540 의 리콜
CARESCAPE Monitor B650 의 리콜
Discovery MR750w 의 리콜
GE Healthcare MRI SystemsTwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, & Signa Vibrant Systems 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 131 건
Proteus XR/a X-ray Imaging Systems
모델명 / 제조번호(시리얼번호)
Proteus XR/a X-ray Imaging SystemsModel Number: 600-0301 ARTG Number: 98099
Innova 2121IQ and Innova 3131IQ Cardiovascular X-Ray Imaging Systems (diagnostic fluoroscopic ang...
모델명 / 제조번호(시리얼번호)
Innova 2121IQ and Innova 3131IQ Cardiovascular X-Ray Imaging Systems (diagnostic fluoroscopic angiography x-ray system)ARTG Number: 93871
Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient m...
모델명 / 제조번호(시리얼번호)
Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient monitor).Monitors with software versions 6.0 and later may be affectedARTG Number: 92726
Carescape Monitor B650 (Multi parameter patient monitor)
모델명 / 제조번호(시리얼번호)
Carescape Monitor B650 (Multi parameter patient monitor)ARTG Number: 115304
Carescape Monitor B850, all software versions (mutliparameter patient monitor)
모델명 / 제조번호(시리얼번호)
Carescape Monitor B850, all software versions (mutliparameter patient monitor)ARTG Number: 92726
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GE Healthcare Australia Pty Ltd
제조사 모회사 (2017)
General Electric Company
Source
RLMPH
Language
English
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