GE Healthcare, LLC
324 recalls on record · Latest: Aug 31, 2022
FDA Devices Moderate Oct 27, 2021
SIGNA Architect nuclear magnetic resonance imaging system
FDA Devices Moderate Oct 27, 2021
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
FDA Devices Moderate Oct 27, 2021
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
FDA Devices Moderate Oct 27, 2021
SIGNA Voyager nuclear magnetic resonance imaging system
FDA Devices Moderate Oct 27, 2021
SIGNA Artist nuclear magnetic resonance imaging system
FDA Devices Moderate Oct 27, 2021
Discovery MR750 3.0T nuclear magnetic resonance imaging system
FDA Devices Moderate Oct 6, 2021
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva…
FDA Devices Moderate Sep 29, 2021
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various ima…
FDA Devices Moderate Sep 29, 2021
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imagi…
FDA Devices Moderate Aug 4, 2021
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
FDA Devices Moderate Jul 21, 2021
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short …
FDA Devices Moderate Jul 21, 2021
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Jul 21, 2021
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
FDA Devices Moderate Jul 21, 2021
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, an…
FDA Devices Moderate Jul 21, 2021
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Jul 21, 2021
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Jul 21, 2021
SIGNA MR380, Nuclear Magnetic Resonance Imaging System
FDA Devices Moderate Jul 14, 2021
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles …
FDA Devices Moderate Jul 14, 2021
Revolution CT
FDA Devices Moderate Jul 7, 2021
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
FDA Devices Moderate Jun 23, 2021
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840…
FDA Devices Moderate May 19, 2021
NM/CT 860 Nuclear Medicine / CT Scanners
FDA Devices Moderate Feb 24, 2021
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
FDA Devices Moderate Feb 17, 2021
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor…
FDA Devices Moderate Jan 20, 2021
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope …
FDA Devices Moderate Jan 20, 2021
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for gen…
FDA Devices Moderate Jan 20, 2021
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Prod…
FDA Devices Moderate Jan 20, 2021
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…
FDA Devices Moderate Jan 20, 2021
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…
FDA Devices Moderate Jan 20, 2021
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer …
FDA Devices Moderate Dec 30, 2020
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
FDA Devices Moderate Dec 30, 2020
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
FDA Devices Moderate Dec 16, 2020
MAC VU360, Electrocardiograph
FDA Devices Moderate Nov 11, 2020
Flow Sensor Service Part, Catalog 2089610-001-S
FDA Devices Moderate Nov 11, 2020
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional …
FDA Devices Moderate Nov 11, 2020
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
FDA Devices Moderate Nov 11, 2020
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide ran…
FDA Devices Moderate Nov 11, 2020
Flow Sensor Service Part, Catalog 2096513-001-S
FDA Devices Moderate Nov 4, 2020
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular …
FDA Devices Moderate Oct 28, 2020
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign…
FDA Devices Moderate Sep 30, 2020
NM/CT 850 Model Number: H3907AD
FDA Devices Moderate Sep 30, 2020
Discovery NM 630 Model # H3101RH
FDA Devices Moderate Sep 30, 2020
Discovery NM670 Pro Model # H3100XB
FDA Devices Moderate Aug 12, 2020
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-par…
FDA Devices Moderate Jul 1, 2020
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042…
FDA Devices Moderate Jun 24, 2020
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
FDA Devices Moderate Jun 24, 2020
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
FDA Devices Moderate Jun 10, 2020
System, Tomography Computed Emmission
FDA Devices Moderate Jun 3, 2020
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
FDA Devices Moderate May 6, 2020