FDA Device Recalls

Recalls / Firms / GE Healthcare

GE Healthcare

189 FDA device recalls on record.

DateClassProductReason
2026-01-16GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 211034
2025-02-19GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015;
2025-02-19GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001
2025-02-19GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3)
2025-02-19GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3
2025-02-19GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-
2024-10-03GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JIN
2024-08-29GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a) 20
2024-08-05GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
2024-07-23GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008;
2023-09-14Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing Syst
2023-09-14Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Process
2023-09-14Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Ima
2023-09-08Universal Viewer Workflow Manager, Image processing radiological system
2023-09-08Centricity Universal Viewer Workflow Manager, Image processing radiological system
2023-03-28Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-
2023-03-28Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c)
2023-03-28Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-0
2020-05-08The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during di
2018-02-23GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Cen
2018-01-25Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Vi
2018-01-25Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a dev
2015-09-28The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mam
2015-09-28The Centricity Universal Viewer Version is a device that displays medical images (including mammogra
2015-09-16Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical imag
2015-08-31GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The in
2015-08-31GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5
2015-08-31GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic re
2015-08-31GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonan
2015-08-31GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
2015-08-31GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole bo
2015-08-31GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family
2015-08-11Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal View
2015-08-11Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is
2015-07-17PET Discovery ST 16
2015-07-17PET Discovery LS
2015-07-17Lightspeed 16 CT
2015-07-10GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed
2015-06-12GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A u
2015-06-12GE Healthcare, Precision MPi fluoroscopic imaging systems.
2015-06-12GE Healthcare Precision 500D Classical R & F system.
2015-06-12GE Healthcare Precision RXi Digital system
2015-06-12GE Healthcare Precision RXi 23A/32A Analog System
2015-05-29GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotatio
2015-05-29GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rot
2015-05-29GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotatio
2015-05-29GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotati
2015-05-29GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotatio
2015-05-29GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotati
2015-05-29GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotati
2015-05-29GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotati
2015-05-29GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotati
2015-05-29GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotati
2015-05-29GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in
2015-05-29GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotatio
2015-05-29GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotati
2015-05-04GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
2015-04-24D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules
2015-04-22CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole
2015-03-12GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measureme
2015-03-09GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGN
2015-03-09Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging sy
2015-03-05GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations.
2015-02-27GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intend
2015-02-16GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 40
2015-01-30GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating rad
2015-01-27GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000,
2015-01-07This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR4
2014-12-19GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
2014-12-19GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
2014-12-19GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
2014-12-19GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
2014-12-10GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray sy
2014-12-08GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
2014-11-12The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient tab
2014-10-24GE Discovery MR950 MRI system
2014-04-03The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for di
2014-04-02Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are u
2014-04-02Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates
2014-04-02Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a th
2014-04-02Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonat
2014-04-02Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who ar
2013-12-12Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part **
2013-12-12Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568,
2013-12-12Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part *
2013-12-12Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare
2013-12-12Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Lau
2013-12-12Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001,
2013-02-18The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for di
2009-10-01Discovery CT 750 HD model numbers: 5232083, 5232083-2, 5232083-3, and 5232083-4. For head, whole bo
2009-10-01LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 51299
2009-08-12GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
2009-08-12GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
2009-02-24GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring.
2009-02-19GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System
2009-02-05GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.
2009-02-05GE Datex-Ohmeda Advance Anesthesia Gas-Machine.
2009-02-01DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1,
2009-02-01iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0
2009-02-01DPX-NT series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1,
2009-02-01DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1,
2009-02-01Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 1
2009-01-26GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05,
2008-10-30Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic
2008-10-30Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthesia and ve
2008-10-30GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory s
2008-10-09GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 (
2008-10-09GE Innova 3100, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consist
2008-10-09GE Innova 4100-IQ, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positio
2008-10-09GE Innova 4100, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner
2008-10-09GE Innova 3100-IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system cons
2008-07-25Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system
2008-07-25Innova 2000; The principle system components include a C-arm, image acquisition, processing and arch
2008-07-25Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane pos
2008-07-25Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vasc
2008-07-01GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system
2008-07-01GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system
2008-06-24GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 (
2008-06-24GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The syst
2008-06-24GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplan
2008-06-24Innova 2000 The principle system components include a C-arm, image acquisition, processing and archi
2008-06-24Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the fir
2008-06-24Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic angiogra
2008-05-01GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product is used
2008-05-01Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numb
2008-05-01GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Ameri
2008-05-01GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA The product is used
2008-05-01GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA The product is used
2008-04-23GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a
2008-04-02GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended
2008-04-01GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2
2008-03-28GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107
2008-03-10DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti
2008-03-07GE Healthcare Definium 8000 Digital Radiographic System.
2008-03-07GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d wit
2008-01-14Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane systems are t
2008-01-14Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascular or cardi
2008-01-14Innova 2000's principle system components include a C-arm, image acquisition, processing and archivi
2008-01-14Advantx-E is an angiographic X-Ray system.
2008-01-14Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane positioner, a
2008-01-14Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monoplane positi
2008-01-02GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000
2008-01-02Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 2183000, 2206
2008-01-02GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 240
2007-12-18GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F System. It is a remote R&F system cons
2007-12-18GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote analog R&F s
2007-12-18GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote analog R&F syst
2007-12-17GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2. The Definiu
2007-12-17GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definium
2007-12-14GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce
2007-12-14GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used as a diagnosti
2007-12-13S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, G
2007-11-15GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The syst
2007-11-15GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplan
2007-11-15GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188
2007-11-01GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as t
2007-10-21GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option.
2007-10-21GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option.
2007-10-04GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System. Model #2289299-2, with console
2007-10-01GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System. Model Numbers 5107849, 5107849-2, M
2007-10-01GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. Indicated
2007-09-10GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2
2007-08-13GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview
2007-08-13GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems. GE Healthcare, 3000 Nort
2007-08-01Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145,
2007-08-01Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray syste
2007-07-06GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations
2007-03-29GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
2007-03-09Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactur
2006-12-31Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860,
2006-12-21GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6, 2357739-7 and 235
2006-12-21GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3.
2006-12-21GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System.
2006-12-21GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system.
2006-12-21GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems.
2006-12-08The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications
2006-12-08The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed Tomography
2006-11-01GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F
2006-08-04GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -T
2006-06-23ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patie
2006-06-06GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system
2006-03-22Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia De
2006-03-06GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital Fluorosc
2006-03-06GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiovascular Im
2006-03-06GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. C
2005-11-16Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)
2005-04-18GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera. This system is a mult
2005-04-18GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized nuclear
2005-04-18GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modular nucle