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All Recalls

Every Ge Healthcare, Llc Recall

Sorted by most recent. Click any recall for full details.

309 recalls
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima CT540 X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery IQ X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Ge Healthcare, Llc
Infant Warmer System (IWS)
Medical Devices·34,986 affected·May 5, 2017
High RiskFDA
Ge Healthcare, Llc
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Medical Devices·3,448 affected·May 2, 2017
High RiskFDA
Ge Healthcare, Llc
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Medical Devices·396 affected·Mar 10, 2017
High RiskFDA
Ge Healthcare, Llc
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Medical Devices·971 affected·Mar 10, 2017
High RiskFDA
Ge Healthcare, Llc
Prestige VH
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
Precision 500D
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
ADVANTX LCA
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
Prestige SI
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
RFX
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
ADVANTX LCV+
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
Prestilix
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
Innova 2000
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
Legacy
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Avance, Avance CS2, Amingo.
Medical Devices·23,098 affected·Nov 3, 2016
High RiskFDA
Ge Healthcare, Llc
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Diagnostic Devices·58 affected·Sep 16, 2016
High RiskFDA
Ge Healthcare, Llc
Infant Warmer System (IWS)
Medical Devices·32,073 affected·Aug 4, 2016
CriticalFDA
Ge Healthcare, Llc
GE Healthcare, Discovery MR750w
Medical Devices·471 affected·Jun 8, 2016
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: ...
Medical Devices·147 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H...
Medical Devices·255 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine i...
Medical Devices·29 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3...
Medical Devices·22 affected·Oct 14, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Carescape Patient Data Module
Medical Devices·68,452 affected·Sep 19, 2014
High RiskFDA
Ge Healthcare, Llc
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anat...
Diagnostic Devices·10 affected·Sep 4, 2014
High RiskFDA
Ge Healthcare, Llc
Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human a...
Diagnostic Devices·1 affected·Sep 4, 2014
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service ...
Respiratory Devices·748 affected·Aug 8, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest,...
Medical Devices·334 affected·Jul 25, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport w...
Medical Devices·21,799 affected·Jul 7, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Medical Devices·41,992 affected·Jun 13, 2014
CriticalFDA
Ge Healthcare, Llc
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N...
Medical Devices·2,948 affected·Jun 11, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated fo...
Diagnostic Devices·1,053 affected·Jun 4, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all ...
Diagnostic Devices·3,460 affected·Jun 4, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module,...
Respiratory Devices·4,961 affected·May 23, 2014
High RiskFDA
Ge Healthcare, Llc
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex S...
Surgical Devices·3,221 affected·May 2, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discover...
Diagnostic Devices·1,548 affected·Apr 23, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monito...
Medical Devices·1,794 affected·Apr 9, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]....
Cardiac Devices·101 affected·Apr 7, 2014
High RiskFDA
Ge Healthcare, Llc
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
Cardiac Devices·447 affected·Mar 27, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 ser...
Cardiac Devices·33 affected·Feb 14, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feat...
Cardiac Devices·10,211 affected·Feb 13, 2014
High RiskFDA
Ge Healthcare, Llc
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to ...
Diagnostic Devices·3,062 affected·Feb 7, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medici...
Diagnostic Devices·3,062 affected·Feb 7, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option...
Medical Devices·359 affected·Jan 20, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor inten...
Cardiac Devices·40,239 affected·Dec 27, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to ...
Diagnostic Devices·816 affected·Dec 12, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray i...
Surgical Devices·257 affected·Dec 11, 2013
High RiskFDA
Ge Healthcare, Llc
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patien...
Cardiac Devices·2,516 affected·Dec 5, 2013