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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 - Product Usage: is a whole body magnetic resonance scanner designed to support...
Medical Devices·62 affected·Dec 23, 2019
High RiskFDA
Ge Healthcare, Llc
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support h...
Medical Devices·62 affected·Dec 23, 2019
High RiskFDA
Ge Healthcare, Llc
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support h...
Medical Devices·62 affected·Dec 23, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare i...
Medical Devices·205 affected·Dec 16, 2019
High RiskFDA
Ge Healthcare, Llc
Lunar iDXA bone densitometer
Medical Devices·123 affected·Dec 3, 2019
High RiskFDA
Ge Healthcare, Llc
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
Medical Devices·123 affected·Dec 3, 2019
High RiskFDA
Ge Healthcare, Llc
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
Medical Devices·123 affected·Dec 3, 2019
CriticalFDA
Ge Healthcare, Llc
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory su...
Respiratory Devices·280 affected·Nov 25, 2019
High RiskFDA
Ge Healthcare, Llc
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed hea...
Medical Devices·11,347 affected·Nov 12, 2019
High RiskFDA
Ge Healthcare, Llc
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and ...
Medical Devices·41,848 affected·Nov 12, 2019
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data with...
Medical Devices·10,661 affected·Nov 12, 2019
CriticalFDA
Ge Healthcare, Llc
Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
Medical Devices·3,467 affected·Oct 11, 2019
CriticalFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Module E-sCAiOV
Respiratory Devices·37 affected·Sep 27, 2019
CriticalFDA
Ge Healthcare, Llc
Airway Gas Option N-CAiO
Medical Devices·12 affected·Sep 27, 2019
CriticalFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Module E-sCAiO
Respiratory Devices·161 affected·Sep 27, 2019
CriticalFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Module E-sCAiOVE
Respiratory Devices·14 affected·Sep 27, 2019
High RiskFDA
Ge Healthcare, Llc
Achilles Express Bone Sonometer
Medical Devices·241 affected·Sep 3, 2019
High RiskFDA
Ge Healthcare, Llc
Achilles Insight Bone Sonometer
Medical Devices·599 affected·Sep 3, 2019
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mo...
Medical Devices·59 affected·Jul 26, 2019
High RiskFDA
Ge Healthcare, Llc
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-...
Medical Devices·7,168 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
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...
Medical Devices·19,351 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
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...
Medical Devices·473 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
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) 1006-931...
Medical Devices·502 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
Medical Devices·3 affected·Jul 2, 2019
High RiskFDA
Ge Healthcare, Llc
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Medical Devices·2 affected·Jul 2, 2019
High RiskFDA
Ge Healthcare, Llc
MAC VU360, Model Number 2030360-001, Electrocardiograph
Medical Devices·369 affected·Jun 28, 2019
High RiskFDA
Ge Healthcare, Llc
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) 20...
Medical Devices·620 affected·May 22, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device...
Diagnostic Devices·50 affected·May 17, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal V...
Medical Devices·292 affected·May 17, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthc...
Medical Devices·145 affected·May 16, 2019
High RiskFDA
Ge Healthcare, Llc
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in t...
Medical Devices·82 affected·May 16, 2019
RecallFDA
Ge Healthcare, Llc
Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002...
Medical Devices·58,045 affected·May 10, 2019
RecallFDA
Ge Healthcare, Llc
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 c...
Medical Devices·58,045 affected·May 10, 2019
RecallFDA
Ge Healthcare, Llc
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...
Medical Devices·58,045 affected·May 10, 2019
High RiskFDA
Ge Healthcare, Llc
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general ra...
Medical Devices·825 affected·Mar 29, 2019
High RiskFDA
Ge Healthcare, Llc
Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
Medical Devices·825 affected·Mar 29, 2019
High RiskFDA
Ge Healthcare, Llc
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a spac...
Medical Devices·825 affected·Mar 29, 2019
High RiskFDA
Ge Healthcare, Llc
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requireme...
Medical Devices·825 affected·Mar 29, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Me...
Cardiac Devices·16 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health prof...
Medical Devices·27 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained h...
Medical Devices·11 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detect...
Medical Devices·35 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medici...
Medical Devices·37 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of rad...
Medical Devices·6 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radiois...
Medical Devices·31 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiov...
Diagnostic Devices·22 affected·Mar 15, 2019
CriticalFDA
Ge Healthcare, Llc
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-r...
Medical Devices·28,094 affected·Mar 15, 2019
RecallFDA
Ge Healthcare, Llc
Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA,...
Medical Devices·288 affected·Feb 22, 2019