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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
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitorin...
Cardiac Devices·1,948 affected·Dec 5, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
Medical Devices·178,711 affected·Nov 27, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for ...
Diagnostic Devices·376 affected·Nov 20, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems...
Surgical Devices·28 affected·Nov 15, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical to...
Cardiac Devices·464 affected·Oct 25, 2013
High RiskFDA
Ge Healthcare, Llc
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging an...
Cardiac Devices·710 affected·Oct 11, 2013
High RiskFDA
Ge Healthcare, Llc
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by compute...
Medical Devices·272 affected·Oct 9, 2013
CriticalFDA
Ge Healthcare, Llc
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a control...
Respiratory Devices·12 affected·Oct 1, 2013
CriticalFDA
Ge Healthcare, Llc
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage...
Respiratory Devices·12 affected·Oct 1, 2013
CriticalFDA
Ge Healthcare, Llc
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in...
Respiratory Devices·59,721 affected·Sep 19, 2013
High RiskFDA
Ge Healthcare, Llc
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advanta...
Diagnostic Devices·1,458 affected·Sep 19, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patient...
Diagnostic Devices·810 affected·Aug 30, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high ...
Cardiac Devices·828 affected·Aug 13, 2013
High RiskFDA
Ge Healthcare, Llc
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and ser...
Diagnostic Devices·225 affected·Aug 7, 2013
High RiskFDA
Ge Healthcare, Llc
Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an elec...
Medical Devices·31,443 affected·Jul 29, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating...
Surgical Devices·4 affected·Jun 19, 2013
CriticalFDA
Ge Healthcare, Llc
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system i...
Diagnostic Devices·50 affected·Jun 13, 2013
CriticalFDA
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 dete...
Medical Devices·25 affected·Jun 13, 2013
CriticalFDA
Ge Healthcare, Llc
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 syste...
Medical Devices·213 affected·Jun 13, 2013
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Me...
Diagnostic Devices·571 affected·Jun 13, 2013
High RiskFDA
Ge Healthcare, Llc
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthe...
Respiratory Devices·800 affected·May 14, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Medical Devices·445 affected·May 2, 2013
High RiskFDA
Ge Healthcare, Llc
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001...
Cardiac Devices·1,246 affected·Apr 9, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter ...
Medical Devices·28,120 affected·Apr 3, 2013
High RiskFDA
Ge Healthcare, Llc
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The P...
Medical Devices·16,462 affected·Apr 3, 2013
High RiskFDA
Ge Healthcare, Llc
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and obliq...
Diagnostic Devices·70 affected·Mar 28, 2013
High RiskFDA
Ge Healthcare, Llc
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee...
Medical Devices·81 affected·Mar 28, 2013
High RiskFDA
Ge Healthcare, Llc
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·380 affected·Mar 26, 2013
CriticalFDA
Ge Healthcare, Llc
GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagn...
Diagnostic Devices·2,061 affected·Feb 8, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Sus...
Medical Devices·297 affected·Jan 21, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qual...
Cardiac Devices·588 affected·Nov 9, 2012
CriticalFDA
Ge Healthcare, Llc
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Pand...
Respiratory Devices·276 affected·Oct 15, 2012
High RiskFDA
Ge Healthcare, Llc
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare profe...
Medical Devices·210 affected·Oct 12, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Definium 5000 / 5220493 X-Ray System
Medical Devices·312 affected·Sep 26, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Medical Devices·364 affected·Sep 20, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, ...
Medical Devices·179 affected·Sep 20, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121...
Diagnostic Devices·240 affected·Aug 16, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, ...
Diagnostic Devices·217 affected·Aug 1, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Op...
Diagnostic Devices·217 affected·Aug 1, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, ...
Diagnostic Devices·217 affected·Aug 1, 2012
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for u...
Respiratory Devices·12,779 affected·Jul 20, 2012
High RiskFDA
Ge Healthcare, Llc
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Medical Devices·254 affected·Jul 10, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW ap...
Medical Devices·429 affected·Jun 28, 2012
CriticalFDA
Ge Healthcare, Llc
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 ...
Medical Devices·209,804 affected·Jun 26, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor...
Medical Devices·10,497 affected·Jun 13, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
Medical Devices·119,262 affected·Jun 13, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
Medical Devices·279 affected·Jun 12, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for...
Diagnostic Devices·864 affected·Jun 8, 2012