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GE Healthcare LLC

397 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body atten recall (Z-1745-2019)GE Healthcare, LLC2019-06-19
Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body atten recall (Z-1746-2019)GE Healthcare, LLC2019-06-19
Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body a recall (Z-1747-2019)GE Healthcare, LLC2019-06-19
Discovery IQ Product Usage: The systems are intended for head and whole body attenuation c recall (Z-1748-2019)GE Healthcare, LLC2019-06-19
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation c recall (Z-1749-2019)GE Healthcare, LLC2019-06-19
Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuatio recall (Z-1750-2019)GE Healthcare, LLC2019-06-19
Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional recall (Z-1751-2019)GE Healthcare, LLC2019-06-10
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a confi recall (Z-1752-2019)GE Healthcare, LLC2019-06-10
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology recall (Z-1753-2019)GE Healthcare, LLC2019-06-10
Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal d recall (Z-1754-2019)GE Healthcare, LLC2019-06-10
Silhouette VR This fully integrated system offers intuitive controls with advanced applica recall (Z-1755-2019)GE Healthcare, LLC2019-06-10
Revolution CT systems with the SmartStep Option The system is intended for head, whole bod recall (Z-0776-2019)GE Healthcare, LLC2019-02-06
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model recall (Z-0788-2019)GE Healthcare, LLC2019-01-30
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (singl recall (Z-0463-2019)GE Healthcare, LLC2018-11-30
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition Sy recall (Z-0369-2019)GE Healthcare, LLC2018-11-14
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL recall (Z-0370-2019)GE Healthcare, LLC2018-11-14
GE Healthcare Millennium MC recall (Z-0371-2019)GE Healthcare, LLC2018-11-14
Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X recall (Z-0411-2019)GE Healthcare, LLC2018-11-09
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO recall (Z-0412-2019)GE Healthcare, LLC2018-11-09
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 1 recall (Z-0413-2019)GE Healthcare, LLC2018-11-09
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System recall (Z-2523-2018)GE Healthcare, LLC2018-07-16
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The recall (Z-1292-2018)GE Healthcare, LLC2018-03-14
Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica recall (Z-1293-2018)GE Healthcare, LLC2018-03-14
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 recall (Z-2703-2017)GE Healthcare, LLC2017-05-24
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems recall (Z-2179-2017)GE Healthcare, LLC2017-05-22
Infant Warmer System (IWS) recall (Z-2323-2017)GE Healthcare, LLC2017-05-19
Discovery MR450 The systems are whole body magnetic resonance scanners designed to support recall (Z-1188-2017)GE Healthcare, LLC2017-02-10
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device recall (Z-1927-2016)GE Healthcare, LLC2016-06-08
Optima 1.5T MR430s MR Scanner, a diagnostic imaging device recall (Z-1928-2016)GE Healthcare, LLC2016-06-08
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, recall (Z-0184-2015)GE Healthcare, LLC2014-12-16
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD recall (Z-0185-2015)GE Healthcare, LLC2014-12-16
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models recall (Z-0186-2015)GE Healthcare, LLC2014-12-16
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3 recall (Z-0187-2015)GE Healthcare, LLC2014-12-16
Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system i recall (Z-0188-2015)GE Healthcare, LLC2014-12-16
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models recall (Z-0189-2015)GE Healthcare, LLC2014-12-16
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluo recall (Z-0451-2015)GE Healthcare, LLC2014-12-16
Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating f recall (Z-0452-2015)GE Healthcare, LLC2014-12-16
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vas recall (Z-0453-2015)GE Healthcare, LLC2014-12-16
GE Healthcare Carescape Patient Data Module recall (Z-0060-2015)GE Healthcare, LLC2014-10-09
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F recall (Z-0010-2015)GE Healthcare, LLC2014-10-02
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the A recall (Z-2617-2014)GE Healthcare, LLC2014-09-09
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiogra recall (Z-2291-2014)GE Healthcare, LLC2014-08-20
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use recall (Z-2114-2014)GE Healthcare, LLC2014-07-24
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. recall (Z-2085-2014)GE Healthcare, LLC2014-07-21
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM F recall (Z-2068-2014)GE Healthcare, LLC2014-07-18
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating recall (Z-1988-2014)GE Healthcare, LLC2014-07-02
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital recall (Z-1989-2014)GE Healthcare, LLC2014-07-02
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. T recall (Z-1808-2014)GE Healthcare, LLC2014-06-17
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Sur recall (Z-1706-2014)GE Healthcare, LLC2014-06-03
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda recall (Z-1640-2014)GE Healthcare, LLC2014-05-21
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with recall (Z-1533-2014)GE Healthcare, LLC2014-05-01
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analy recall (Z-1511-2014)GE Healthcare, LLC2014-04-25
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in recall (Z-1488-2014)GE Healthcare, LLC2014-04-23
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discov recall (Z-1480-2014)GE Healthcare, LLC2014-04-21
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. T recall (Z-1245-2014)GE Healthcare, LLC2014-03-20
GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable recall (Z-1198-2014)GE Healthcare, LLC2014-03-13
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Qua recall (Z-1199-2014)GE Healthcare, LLC2014-03-13
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usag recall (Z-1200-2014)GE Healthcare, LLC2014-03-13
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor recall (Z-1175-2014)GE Healthcare, LLC2014-03-11
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innov recall (Z-1163-2014)GE Healthcare, LLC2014-03-10
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5. recall (Z-1147-2014)GE Healthcare, LLC2014-03-06
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW recall (Z-1148-2014)GE Healthcare, LLC2014-03-06
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant recall (Z-1070-2014)GE Healthcare, LLC2014-02-25
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone In recall (Z-1071-2014)GE Healthcare, LLC2014-02-25
GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant war recall (Z-1072-2014)GE Healthcare, LLC2014-02-25
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography O recall (Z-1078-2014)GE Healthcare, LLC2014-02-24
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE D recall (Z-0981-2014)GE Healthcare, LLC2014-02-14
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Sta recall (Z-0982-2014)GE Healthcare, LLC2014-02-14
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in recall (Z-0927-2014)GE Healthcare, LLC2014-02-04
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Pre recall (Z-0911-2014)GE Healthcare, LLC2014-02-03
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Pr recall (Z-0853-2014)GE Healthcare, LLC2014-01-28
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B65 recall (Z-0854-2014)GE Healthcare, LLC2014-01-28
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cro recall (Z-0840-2014)GE Healthcare, LLC2014-01-27
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the recall (Z-0806-2014)GE Healthcare, LLC2014-01-22
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE recall (Z-0807-2014)GE Healthcare, LLC2014-01-22
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module recall (Z-0808-2014)GE Healthcare, LLC2014-01-22
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray recall (Z-0804-2014)GE Healthcare, LLC2014-01-21
GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to p recall (Z-0747-2014)GE Healthcare, LLC2014-01-14
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. M recall (Z-0725-2014)GE Healthcare, LLC2014-01-11
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE recall (Z-0648-2014)GE Healthcare, LLC2014-01-09
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package recall (Z-0472-2014)GE Healthcare, LLC2013-12-13
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor recall (Z-0489-2014)GE Healthcare, LLC2013-12-12
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, whic recall (Z-0373-2014)GE Healthcare, LLC2013-11-21
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The G recall (Z-0367-2014)GE Healthcare, LLC2013-11-20
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANG recall (Z-0270-2014)GE Healthcare, LLC2013-11-13
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a recall (Z-0012-2014)GE Healthcare, LLC2013-10-17
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 410 recall (Z-0021-2014)GE Healthcare, LLC2013-10-17
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer recon recall (Z-0023-2014)GE Healthcare, LLC2013-10-17
GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corr recall (Z-0024-2014)GE Healthcare, LLC2013-10-17
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure cont recall (Z-0009-2014)GE Healthcare, LLC2013-10-15
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume recall (Z-0010-2014)GE Healthcare, LLC2013-10-15
GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanne recall (Z-2291-2013)GE Healthcare, LLC2013-09-27
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model recall (Z-2266-2013)GE Healthcare, LLC2013-09-23
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter pat recall (Z-2256-2013)GE Healthcare, LLC2013-09-19
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 518368 recall (Z-2257-2013)GE Healthcare, LLC2013-09-19
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. recall (Z-2241-2013)GE Healthcare, LLC2013-09-18
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray recall (Z-2253-2013)GE Healthcare, LLC2013-09-18
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a profess recall (Z-2201-2013)GE Healthcare, LLC2013-09-16
Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec recall (Z-2161-2013)GE Healthcare, LLC2013-09-06
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the recall (Z-2115-2013)GE Healthcare, LLC2013-08-28
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