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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
SIGNA Architect nuclear magnetic resonance imaging system
Medical Devices·2 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Medical Devices·6 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
Medical Devices·13 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Voyager nuclear magnetic resonance imaging system
Medical Devices·15 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Artist nuclear magnetic resonance imaging system
Medical Devices·18 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR750 3.0T nuclear magnetic resonance imaging system
Medical Devices·5 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from...
Medical Devices·462 affected·Aug 6, 2021
High RiskFDA
Ge Healthcare, Llc
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from v...
Medical Devices·392 affected·Aug 6, 2021
High RiskFDA
Ge Healthcare, Llc
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; ...
Medical Devices·310,072 affected·Aug 2, 2021
High RiskFDA
Ge Healthcare, Llc
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at diffe...
Cardiac Devices·0 affected·Jun 30, 2021
High RiskFDA
Ge Healthcare, Llc
Revolution Apex, Revolution CT with Apex Edition
Medical Devices·273 affected·Jun 30, 2021
High RiskFDA
Ge Healthcare, Llc
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Medical Devices·3,665 affected·Jun 14, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio...
Medical Devices·100 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
Medical Devices·562 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Medical Devices·71 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noi...
Medical Devices·585 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Medical Devices·91 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Medical Devices·40 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Medical Devices·111,728 affected·May 21, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7...
Medical Devices·139 affected·Apr 19, 2021
High RiskFDA
Ge Healthcare, Llc
Revolution CT
Medical Devices·197 affected·Mar 19, 2021
High RiskFDA
Ge Healthcare, Llc
NM/CT 860 Nuclear Medicine / CT Scanners
Medical Devices·242 affected·Feb 7, 2021
High RiskFDA
Ge Healthcare, Llc
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Medical Devices·1,115 affected·Dec 17, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of r...
Medical Devices·12 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: inte...
Medical Devices·81 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H31...
Medical Devices·52 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/tr...
Diagnostic Devices·113 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radio...
Medical Devices·24 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radio...
Medical Devices·12 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioiso...
Medical Devices·7 affected·Dec 10, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Cardiac Devices·2 affected·Nov 23, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography ...
Cardiac Devices·3 affected·Nov 23, 2020
High RiskFDA
Ge Healthcare, Llc
MAC VU360, Electrocardiograph
Medical Devices·5,284 affected·Oct 27, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac a...
Cardiac Devices·64 affected·Sep 21, 2020
High RiskFDA
Ge Healthcare, Llc
Flow Sensor Service Part, Catalog 2089610-001-S
Medical Devices·4,794 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the c...
Respiratory Devices·2 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Medical Devices·37 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support t...
Respiratory Devices·88 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Flow Sensor Service Part, Catalog 2096513-001-S
Medical Devices·2 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolutio...
Medical Devices·30 affected·Sep 8, 2020
High RiskFDA
Ge Healthcare, Llc
NM/CT 850 Model Number: H3907AD
Medical Devices·25 affected·Aug 14, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630 Model # H3101RH
Medical Devices·62 affected·Aug 14, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery NM670 Pro Model # H3100XB
Medical Devices·9 affected·Aug 14, 2020
High RiskFDA
Ge Healthcare, Llc
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to...
Medical Devices·8,414 affected·Jun 22, 2020
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Nu...
Medical Devices·89,109 affected·May 18, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Respiratory Devices·5,883 affected·Apr 28, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Respiratory Devices·5,883 affected·Apr 28, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Medical Devices·204 affected·Apr 2, 2020