GE Healthcare, LLC
324 recalls on record · Latest: Aug 31, 2022
FDA Devices Moderate May 6, 2020
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
FDA Devices Moderate May 6, 2020
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
FDA Devices Moderate Feb 5, 2020
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolu…
FDA Devices Moderate Feb 5, 2020
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resoluti…
FDA Devices Moderate Feb 5, 2020
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resoluti…
FDA Devices Moderate Jan 29, 2020
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information s…
FDA Devices Critical Jan 29, 2020
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a w…
FDA Devices Critical Jan 22, 2020
CARESCAPE Respiratory Module E-sCAiOV
FDA Devices Critical Jan 22, 2020
Airway Gas Option N-CAiO
FDA Devices Critical Jan 22, 2020
CARESCAPE Respiratory Module E-sCAiO
FDA Devices Critical Jan 22, 2020
CARESCAPE Respiratory Module E-sCAiOVE
FDA Devices Moderate Jan 1, 2020
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare prac…
FDA Devices Moderate Jan 1, 2020
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal pat…
FDA Devices Moderate Jan 1, 2020
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospita…
FDA Devices Moderate Dec 25, 2019
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 100…
FDA Devices Moderate Dec 25, 2019
Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 …
FDA Devices Moderate Dec 25, 2019
Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7…
FDA Devices Moderate Dec 25, 2019
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243…
FDA Devices Critical Dec 11, 2019
Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
FDA Devices Moderate Nov 13, 2019
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the ot…
FDA Devices Moderate Oct 16, 2019
Achilles Express Bone Sonometer
FDA Devices Moderate Oct 16, 2019
Achilles Insight Bone Sonometer
FDA Devices Moderate Aug 7, 2019
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis…
FDA Devices Moderate Jul 31, 2019
MAC VU360, Model Number 2030360-001, Electrocardiograph
FDA Devices Moderate Jul 24, 2019
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
FDA Devices Moderate Jul 24, 2019
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
FDA Devices Moderate Jul 24, 2019
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
FDA Devices Critical Jul 17, 2019
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate base…
FDA Devices Critical Jul 17, 2019
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate ba…
FDA Devices Moderate Jul 10, 2019
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare informat…
FDA Devices Low Jul 3, 2019
Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwir…
FDA Devices Low Jul 3, 2019
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 21…
FDA Devices Low Jul 3, 2019
ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, …
FDA Devices Moderate Jul 3, 2019
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displa…
FDA Devices Moderate Jul 3, 2019
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a d…
FDA Devices Moderate Jun 26, 2019
Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging…
FDA Devices Moderate Jun 26, 2019
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging an…
FDA Devices Moderate Jun 26, 2019
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vsc…
FDA Devices Moderate Jun 19, 2019
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology appl…
FDA Devices Moderate Jun 19, 2019
Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
FDA Devices Moderate Jun 19, 2019
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving des…
FDA Devices Moderate Jun 19, 2019
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The sys…
FDA Devices Moderate Jun 19, 2019
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d…
FDA Devices Moderate May 8, 2019
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imagi…
FDA Devices Moderate May 8, 2019
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to…
FDA Devices Moderate May 8, 2019
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health profes…
FDA Devices Moderate May 8, 2019
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radio…
FDA Devices Moderate May 8, 2019
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging p…
FDA Devices Moderate May 8, 2019
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tr…
FDA Devices Moderate May 8, 2019