GE Healthcare, LLC: Medical Device Recalls in 2020

According to to data from the FDA, there were 53 medical device recalls made by GE Healthcare, LLC in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• CARESCAPE Respiratory Module E-sCAiOV
• CARESCAPE Respiratory Module E-sCO
• Airway Gas Option N-CAiO
• Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
• Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
• Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
• CARESCAPE Respiratory Module E-sCAiOVE
• CARESCAPE Respiratory Module E-sCAiO
• CARESCAPE Respiratory Module E-sCAiOE
• CARESCAPE Respiratory Module E-sCOVX
• Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
• SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
• SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
• Lunar iDXA bone densitometer
• SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
• SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
• Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
• Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
• Discovery NM 630 Model # H3101RH
• CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474 2042084-001-053034 2042084-001-215165 2042084-001-079462 2042084-001-047389 2042084-001-112198 2042084-001-041673 2042084-001-227238 2042084-001-071564 2042084-001-503824 2042084-001-119839 2042084-001-569269 2042084-001-041674 2042084-001-047549 2042084-001-514651 2042084-001-163572 2042084-001-583721 2042084-001-427592 2042084-001-527358 2042084-001-583723 2042084-001-317166 2042084-001-583724 2042084-001-583715 2042084-001-583718 2042084-001-055156 2042084-001-583722 2042084-001-041835 2042084-001-074124 2042084-001-583706 2042084-001-583707 2042084-001-519926 2042084-001-583717 2042084-001-583713 2042084-001-207863 2042084-001-460604 2042084-001-079192 2042084-001-197663 2042084-001-045872 2042084-001-053195 2042084-001-092010 2042084-001-560824 2042084-001-052372 2042084-001-071088 2042084-001-046667 2042084-001-213006 2042084-001-086202 2042084-001-301821 2042084-001-045720 2042084-001-060454 2042084-001-418294 2042084-001-088907 2042084-001-065769 2042084-001-589530 2042084-001-623792 2042084-001-187563 2042084-001-320333 2042084-001-357143 2042084-001-148302 To be provided 2042084-001-082825 2042084-001-057016 2042084-001-153601 2042084-001-161552 2042084-001-140229 2042084-001-611704 2042084-001-626688 2042084-001-389208 2042084-001-657836 2042084-001-225214 2042084-001-503162 2042084-001-477881 2042084-001-316025 2042084-001-046826 2042084-001-245255 2042084-001-196543 2042084-001-557725 2042084-001-505890 2042084-001-218596 2042084-001-336980 2042084-001-524525 2042084-001-600032 2042084-001-529732 2042084-001-195742 2042084-001-195782 2042084-001-573889 2042084-001-573890 2042084-001-573886 2042084-001-573887 2042084-001-195822 2042084-001-195862 2042084-001-048420 2042084-001-065538 2042084-001-055814 2042084-001-341260 2042084-001-149220 2042084-001-079193 2042084-001-229282 2042084-001-629486 2042084-001-058695 2042084-001-061170 2042084-001-629548 2042084-001-080803 2042084-001-596662 2042084-001-250146 2042084-001-202515 2042084-001-515709 2042084-001-579491 2042084-001-505608 2042084-001-065010 2042084-001-619171
• System, Tomography Computed Emmission
• NM 830 Model # H3910AC
• System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
• System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
• Flow Sensor Service Part, Catalog 2087640-001-S
• Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
• Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
• System, Tomography Computed Emmission
• GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.
• System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
• NM/CT 870 CZT Model # H3906CW
• NM/CT 870 DR Model # H3100AS
• Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
• Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.
• MAC VU360, Electrocardiograph
• GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.
• NM/CT 850 Model Number: H3907AD
• NM/CT 860, SPECT/CT
• Discovery NM670 Pro Model # H3100XB
• Flow Sensor Service Part, Catalog 2089610-001-S
• 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
• Flow Sensor Service Part, Catalog 2096513-001-S
• System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
• Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
• Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
• Discovery 670 DR Model # H3100BT
• Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
• CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
• CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
• Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
• CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.
• CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.
• ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.