GE Healthcare, LLC
324 recalls on record · Latest: Aug 31, 2022
FDA Devices Moderate Jun 21, 2017
GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system
FDA Devices Moderate Jun 21, 2017
GE Healthcare Discovery Ml DR X-ray system
FDA Devices Moderate Jun 21, 2017
GE Healthcare Optima CT540 X-ray system
FDA Devices Moderate Jun 21, 2017
GE Healthcare Discovery IQ X-ray system
FDA Devices Moderate Jun 7, 2017
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
FDA Devices Moderate Apr 19, 2017
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
FDA Devices Moderate Apr 19, 2017
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
FDA Devices Moderate Jan 18, 2017
Infant Warmer System (IWS)
FDA Devices Moderate Jan 4, 2017
Prestige VH
FDA Devices Moderate Jan 4, 2017
Precision 500D
FDA Devices Moderate Jan 4, 2017
ADVANTX LCA
FDA Devices Moderate Jan 4, 2017
Prestige SI
FDA Devices Moderate Jan 4, 2017
RFX
FDA Devices Moderate Jan 4, 2017
ADVANTX LCV+
FDA Devices Moderate Jan 4, 2017
Prestilix
FDA Devices Moderate Jan 4, 2017
Innova 2000
FDA Devices Moderate Jan 4, 2017
Legacy
FDA Devices Moderate Dec 21, 2016
GE Healthcare, Avance, Avance CS2, Amingo.
FDA Devices Moderate Jul 13, 2016
GE Healthcare, Discovery MR750w
FDA Devices Moderate Jun 15, 2016
GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended …
FDA Devices Moderate Dec 24, 2014
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for card…
FDA Devices Moderate Dec 24, 2014
Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for c…
FDA Devices Moderate Nov 19, 2014
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Disco…
FDA Devices Moderate Nov 19, 2014
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. …
FDA Devices Moderate Nov 19, 2014
Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging proce…
FDA Devices Moderate Nov 19, 2014
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401…
FDA Devices Moderate Oct 15, 2014
GE Healthcare Carescape Patient Data Module
FDA Devices Moderate Sep 17, 2014
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange uni…
FDA Devices Moderate Aug 27, 2014
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, ex…
FDA Devices Critical Jul 30, 2014
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-FCREC MODUL…
FDA Devices Moderate Jul 30, 2014
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Devices Moderate Jul 30, 2014
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a prof…
FDA Devices Moderate Jul 9, 2014
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in gen…
FDA Devices Moderate Jul 9, 2014
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purp…
FDA Devices Moderate Jun 25, 2014
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, E-CAiOVX fa…
FDA Devices Moderate Jun 11, 2014
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension in…
FDA Devices Moderate May 28, 2014
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the rel…
FDA Devices Moderate May 7, 2014
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5…
FDA Devices Moderate May 7, 2014
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equ…
FDA Devices Moderate Apr 30, 2014
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
FDA Devices Moderate Mar 26, 2014
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Compu…
FDA Devices Moderate Mar 19, 2014
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform gene…
FDA Devices Moderate Mar 19, 2014
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging syste…
FDA Devices Moderate Mar 19, 2014
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging p…
FDA Devices Moderate Mar 19, 2014
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter pa…
FDA Devices Moderate Mar 12, 2014
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) feature enabled.…
FDA Devices Moderate Mar 12, 2014
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW …
FDA Devices Moderate Mar 5, 2014
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), wh…
FDA Devices Critical Mar 5, 2014
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner t…
FDA Devices Critical Mar 5, 2014