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Manufacturers
GE Healthcare Australia Pty Ltd
Manufacturer Parent Company (2017)
General Electric Company
Source
DHTGA
131 Events
Recall of Proteus XR/a X-ray Imaging Systems
Recall of Innova 2121IQ and Innova 3131IQ Cardiovascular X-Ray Imaging Systems (diagnostic fluoroscopic angiography x-ray system)
Recall of Dash 3000/4000/5000 Patient Monitor with software version 6.0 and later (multiparameter patient monitor).
Recall of Carescape Monitor B650 (Multi parameter patient monitor)
Recall of Carescape Monitor B850, all software versions (mutliparameter patient monitor)
Recall of Vital Signs Disposable General Purpose 9 French Temperature probes
Recall of Table pallet for use with Discovery NM/CT 670 & Discovery NM630 (Diagnostic full body CT X-ray system)
Recall of GE Corometrics Qwik Connect Plus Spiral Electrodes (single use electrodes used for electrocardiographs)
Recall of Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers (infant radiant warmer)
Recall of Monitors B20 or B40 Software version VSP-A_1.10 (or earlier) (Multiparameter Patient Monitor)
Recall of OEC 6800 MiniView C-arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray system)
Recall of FlexiView 8800 Mobile C-Arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray system)
Recall of Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control SystemManufactured between August 1 2012 and December 20 2012
Recall of Ventri and Discovery NM 530c (Full body computed tomography (CT) system)
Recall of Dash 3000/4000/5000 (multiparameter patient monitor) & Dash Port 2 (docking station for Dash 3000/4000/5000)
Recall of 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
Recall of Avance CS2 Anesthesia Carestation
Recall of DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and September 2012
Recall of Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems (when used with certain PACS systems)
Recall of Optima MR430s and MSK 1.5T Extreme (MRI System)
Recall of 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant MR Systems (Magnetic Resonance Imaging Systems)
Recall of 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)
Recall of Discovery MR450, MR750, MR750w and Optima MR450w products, running software versions DV22.0_V02, DV22.1_V01, DV23.0_V01 (MRI System)
Recall of Carbon dioxide absorbent canister for use with the Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 anaesthesia systems
Recall of 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 )
Recall of 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)
Recall of GEHC Discovery NM/CT 670 Nuclear Medicine System
Recall of 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
Recall of Disposable Breathing Circuit Kit
Recall of General Purpose 9 French Temperature Probe, Disposable, 400
Recall of ViewPoint 6 Versions 6.2, 6.2.1, 6.3 and 6.31 including OB Pro-Expert Reporting (Ultrasound image management software)
Recall of 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)
Recall of Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)
Recall of Discovery MR450, MR750 and Optima MR450w MRI System
Recall of 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)
Recall of Engstrom Ventilator & Aespire View, Aisys and Avance Anaesthesia MachinesManufactured from 23 April 2013 to 22 July 2013
Recall of B20, B30, B40 Patient Monitors (used for ECG monitoring)
Recall of Avance, Amingo, Aisys Anaesthesia Devices (software version 8.00) and Avance CS Anaesthesia Devices (with software version 10.00)
Recall of Discovery NM/CT 670, Optima NM/CT 640, Discovery NM630 and Brivo NM615 (all configurations) (Nuclear Medicine System)
Recall of 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)
Recall of Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)
Recall of Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system)
Recall of CARESCAPE Monitor B850 (with software versions 1.0.12 and earlier) and CARESCAPE Monitor B650 (with software version 1.1.12 and earlier)
Recall of PDM module with Frame F5-01 used with CARESCAPE Monitor B850
Recall of Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module)
Recall of 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
Recall of PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44
Recall of 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)
Recall of Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII (diagnostic fluoroscopic x-ray systems)
Recall of Optima XR 220amx, Optima XR200amx with Digital Upgrade Mobile X-ray Systems
Recall of 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
Recall of PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity.53 (Nuclear medicine diagnostic system)
Recall of Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor LCD Video Monitor
Recall of Innova 3100, Innova 3100IQ and Innova 2100IQ Cardiovascular X-ray Imaging Systems
Recall of Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5 or 5.6 (multi-function patient monitor)
Recall of Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic x-ray system)
Recall of Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All configurations
Recall of Neuromuscular Transmission Module used with Carescape and Datex-Ohmeda S/5 Anaesthesia monitors
Recall of INNOVA 2121IQ (Cardiovascular X-ray imaging system)
Recall of Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products (Full body magnetic resonance imaging systems)
Recall of 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.
Recall of Kenex suspension arm with radiation shield and/or surgical lamp
Recall of 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
Recall of Panda iRes Warmers integrated with Nellcor SpO2
Recall of 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)
Recall of 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)
Recall of 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)
Recall of CARESCAPE Monitor B650 Software Versions: 1.1.12.26 or earlier
Recall of 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.
Recall of Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systems
Recall of CARESCAPE Monitor B850, B650 or B450 Monitors with V2 software versions (Multiparameter patient monitors)
Recall of CARESCAPE respiratory modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE & the Airway Gas Option N-CAiO
Recall of Discovery XR656 Wall Stand System (X-ray system)
Recall of Patient Data Module (PDM) Used with CARESCAPE Monitor B850, B650, or B450 (Multiparameter Patient Monitor)
Recall of 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.
Recall of 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)
Recall of OEC 9800, OEC UroView 2800, OEC MiniView 6800, OEC FlexiView 8800 (mobile flouroscopic x-ray diagnostic system)Systems supplied in Australia:System: OEC 9800
Recall of Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators
Recall of Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order)
Recall of GE Healthcare MRI systems with superconducting magnets
Recall of Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.
Recall of T2100 and T2000 Treadmill power cords
Recall of Kenex ceiling-suspended radiation shields and surgical lamps
Recall of T2100 Treadmill
Recall of 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
Recall of 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)
Recall of All Precision 500D Radiographic and Fluoroscopic (R&F;) Systems and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic (R&F;) Systems
Recall of Single and dual LCD monitor suspensions used on Precision RXi fluoroscopic imaging systems
Recall of 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.
Recall of GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Power Supply (part number 2334455)
Recall of 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
Recall of Giraffe Shuttle Products (uninterruptable power supply for Giraffe Products)
Recall of Vital Signs LightWand Stylet
Recall of Revolution CT Scanners, software version 15MW03.12
Recall of All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015
Recall of Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems
Recall of Mavig Monitor suspension arms manufactured before January 2009 (used with x-ray fluoroscopic imaging systems) Installed on INNOVA 2100, 3100 fluoroscopic imaging systems.
Recall of 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
Recall of Carestation 620 A1, 650 A1, and 650c A1 Anaesthesia devices and service kits
Recall of PRN 50-M+ Digital Writer
Recall of 3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures)
Recall of SIGNA Pioneer MRI System
Recall of Aisys CS2 and upgraded Aisys anaesthesia devices (with software version 10.X)
Recall of Aisys and Aisys CS2 Anaesthesia machines with the optional Vacuum Suction Function
Recall of Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diagnostic systems)
Recall of GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016
Recall of MSK 1.5T Extreme and Optima MR430s (MRI Systems)
Recall of Revolution CT (diagnostic x-ray system)
Recall of Discovery MR750w (MRI System)
Recall of Infant Warmer System (IWS)
Recall of SIGNA Creator and SIGNA Explorer (MRI System)
Recall of MAGiC (MAGnetic resonance image Compilation) on Signa Pioneer MRI systems running application software version DV25.1
Recall of Avance CS2, Avance, and Amingo anaesthesia devices with the optional large tray insert accessory installed
Recall of Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy and Precision 500D, ADVANTX and Innova 2000 Systems(Diagnostic fluoroscopic x-ray systems)
Recall of Advantx Legacy/Legacy-D Radiographic and Fluoroscopic System
Recall of 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
Recall of Carestation 620, 650 and 650c A1 Anaesthesia devices Carestation
Recall of OEC Elite systemsDistributed between 27 October 2016 and 28 March 2017
Recall of CareScape Patient Data Module (PDM) with software v2.6(used with CareScape Monitors B850, B650 and B450 with v2.0.7 or earlier software)
Recall of 3.0T GE 6-Channel Phased Array Flex Coil
Recall of All Carestation 620, 650 and 650c Anaesthesia systems
Recall of 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.
Recall of CARESCAPE R860 ventilators with software version 10SP05
Recall of CARESCAPE Central Station (CSCS) software version 2.0.2 All-in-one
Recall of Use of Tristel Trio Wipes System with GE TEE probe
Recall of Discovery IGS 730
Recall of Vivid and LOGIQ Ultrasound Systems
Recall of GE Healthcare Revolution EVO & Optima CT Systems CT660, CT670, CT680, CT540
Recall of CARESCAPE Monitor B650
Recall of Discovery MR750w
Recall of 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
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131 devices in the database
Proteus XR/a X-ray Imaging Systems
Model / Serial
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...
Model / Serial
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...
Model / Serial
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)
Model / Serial
Carescape Monitor B650 (Multi parameter patient monitor)ARTG Number: 115304
Carescape Monitor B850, all software versions (mutliparameter patient monitor)
Model / Serial
Carescape Monitor B850, all software versions (mutliparameter patient monitor)ARTG Number: 92726
126 more
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GE Healthcare Australia Pty Ltd
Manufacturer Parent Company (2017)
General Electric Company
Source
RLMPH
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