FDA Device Recalls

Recalls / Firms / GE Healthcare LLC

GE Healthcare LLC

594 FDA device recalls on record.

DateClassProductReason
2026-02-27SIGNA Premier systems
2022-07-15(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, M
2022-06-24SIGNA Premier magnetic resonance scanner, model 5748519.
2022-06-14Centricity PACS Software Version 7.0 SP0.0.4.7
2022-06-08GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical
2022-06-02Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT200
2022-06-01GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2
2022-05-27GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anes
2022-05-10CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023:
2022-04-28Centricity Cardiology CA1000
2022-04-28Centricity Universal Viewer Zero Footprint Client
2022-04-28Centricity Enterprise Web
2022-04-28Centricity PACS RA1000
2022-04-28Centricity Radiology RA600
2022-04-25Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April
2022-04-25Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2
2022-04-18Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Ca
2022-04-18Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b
2022-03-16MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009,
2022-03-04GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA
2022-02-181.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance I
2022-02-18Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
2022-02-18SIGNA Excite 3T. Magnetic Resonance Imaging System
2022-02-181.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
2022-01-28GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS70
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System,
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclea
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear mag
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnet
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 Syst
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR Syste
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nu
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear
2021-12-23GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR Syst
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) Sy
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyag
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 S
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explo
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nucle
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomograp
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear m
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclea
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear m
2021-12-23GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excit
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System,
2021-12-23GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclea
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magne
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIG
2021-12-23GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system,
2021-12-23GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Ex
2021-12-23GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuc
2021-11-04GE Vscan Extend, being sold as "Vscan Extend Sector USB"
2021-11-04GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
2021-11-04GE Vscan Extend, being sold as "Vscan Extend Console"
2021-11-04GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
2021-11-04GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
2021-11-04GE Vscan Extend, being sold as "Vscan Extend Dual USB"
2021-11-04GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
2021-10-15GE Centricity Universal Viewer Zero Footprint Client
2021-08-26SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
2021-08-26SIGNA Premier nuclear magnetic resonance imaging system
2021-08-26SIGNA Architect nuclear magnetic resonance imaging system
2021-08-26Optima MR450w 1.5T nuclear magnetic resonance imaging system
2021-08-26Discovery MR750 3.0T nuclear magnetic resonance imaging system
2021-08-26SIGNA Artist nuclear magnetic resonance imaging system
2021-08-26SIGNA Pioneer nuclear magnetic resonance imaging system
2021-08-26Discovery MR750w 3.0T nuclear magnetic resonance imaging system
2021-08-26SIGNA Voyager nuclear magnetic resonance imaging system
2021-08-261.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
2021-08-12Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
2021-08-06Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images
2021-08-06Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (
2021-08-02Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089
2021-08-02Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN
2021-06-30Revolution Apex, Revolution CT with Apex Edition
2021-06-30The system is intended to produce cross-sectional images of the body by computer reconstruction of x
2021-06-30The system is intended to produce cross-sectional images of the body by computer reconstruction of x
2021-06-30The system is intended to produce cross-sectional images of the body by computer reconstruction of x
2021-06-30Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with
2021-06-30Revolution CT, Revolution CT ES
2021-06-24AMX Navigate Mobile X-Ray System
2021-06-14Revolution EVO, Optima CT660, Optima CT680 CT Systems.
2021-06-04Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to suppor
2021-06-04SIGNA Artist, Nuclear Magnetic Resonance Imaging System
2021-06-04Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
2021-06-04Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support
2021-06-04SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
2021-06-04Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
2021-06-04SIGNA MR380, Nuclear Magnetic Resonance Imaging System
2021-06-041.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
2021-06-04SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
2021-06-04SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high
2021-06-04SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high r
2021-06-04SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high r
2021-06-04SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resona
2021-06-04SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
2021-05-21CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
2021-04-19GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (
2021-04-19Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress
2021-03-19Revolution CT
2021-03-19Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnosti
2021-02-07NM/CT 850 Nuclear Medicine / CT Scanners
2021-02-07NM/CT 860 Nuclear Medicine / CT Scanners
2021-02-07NM/CT 870 DR Nuclear Medicine / CT Scanners
2020-12-17System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
2020-12-17System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
2020-12-10Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model
2020-12-10Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging
2020-12-10GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage
2020-12-10Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model
2020-12-10GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imag
2020-12-10GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imag
2020-12-10GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine
2020-11-23Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed
2020-11-23Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac an
2020-10-27MAC VU360, Electrocardiograph
2020-09-21Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is int
2020-09-17Flow Sensor Service Part, Catalog 2089610-001-S
2020-09-17Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the fu
2020-09-17Flow Sensor Service Part, Catalog 2087640-001-S
2020-09-179100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
2020-09-17Flow Sensor Service Part, Catalog 2096513-001-S
2020-09-17GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalati
2020-09-17GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation
2020-09-08System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scann
2020-09-08System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scann
2020-09-08System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scann
2020-09-08System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scann
2020-09-08Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product
2020-08-14Discovery NM670 Pro Model # H3100XB
2020-08-14Discovery NM 630 Model # H3101RH
2020-08-14NM/CT 860, SPECT/CT
2020-08-14NM/CT 870 DR Model # H3100AS
2020-08-14Discovery 670 DR Model # H3100BT
2020-08-14NM 830 Model # H3910AC
2020-08-14NM/CT 850 Model Number: H3907AD
2020-08-14NM/CT 870 CZT Model # H3906CW
2020-07-14CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically c
2020-06-22CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiologica
2020-05-18CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLA
2020-04-28Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
2020-04-28Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
2020-04-02Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
2019-12-23SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi
2019-12-23SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic
2019-12-23SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic re
2019-12-23SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic re
2019-12-16Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging
2019-12-03Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
2019-12-03Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
2019-12-03Lunar iDXA bone densitometer
2019-12-03Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
2019-11-25Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhal
2019-11-25Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhal
2019-11-12CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, ped
2019-11-12CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide
2019-11-12ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the
2019-10-11Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
2019-10-11Giraffe OmniBed infant warmer
2019-10-11Giraffe Incubator infant warmer
2019-10-11Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, M
2019-09-27Airway Gas Option N-CAiO
2019-09-27CARESCAPE Respiratory Module E-sCAiOV
2019-09-27CARESCAPE Respiratory Module E-sCOVX
2019-09-27CARESCAPE Respiratory Module E-sCO
2019-09-27CARESCAPE Respiratory Module E-sCAiO
2019-09-27CARESCAPE Respiratory Module E-sCAiOVE
2019-09-27CARESCAPE Respiratory Module E-sCAiOE
2019-09-16CardioLab/ComboLab Recording Systems
2019-09-03Achilles Insight Bone Sonometer
2019-09-03Achilles Express Bone Sonometer
2019-08-30ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and A
2019-08-09Proteus XR/a (SlOK : K993090)
2019-07-26Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a
2019-07-19Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-902
2019-07-19Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1
2019-07-19Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000
2019-07-19Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1
2019-07-02Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
2019-07-02Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
2019-06-28MAC VU360, Model Number 2030360-001, Electrocardiograph
2019-05-22GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a
2019-05-21LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM
2019-05-17Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Cent
2019-05-17Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: C
2019-05-16GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images th
2019-05-16Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, d
2019-05-16Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imag
2019-05-16GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina
2019-05-10ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, gr
2019-05-10Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, s
2019-05-10ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/
2019-05-10Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG
2019-05-10Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG
2019-03-29Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnosti
2019-03-29Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digi
2019-03-29Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system
2019-03-29Silhouette VR This fully integrated system offers intuitive controls with advanced applications fo
2019-03-29Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration
2019-03-20NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging
2019-03-20Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imagin
2019-03-20Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended
2019-03-20NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system
2019-03-20NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imagin
2019-03-20Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended
2019-03-20NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system
2019-03-20NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use b
2019-03-20Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT
2019-03-20Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Med
2019-03-19AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-
2019-03-15Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotationa
2019-03-15Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to
2019-03-15Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotationa
2019-03-15Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner t
2019-03-15Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotatio
2019-02-22Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/
2019-02-12Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation c
2019-02-12Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation c
2019-02-12Discovery Ml Product Usage: The systems are intended for head and whole body attenuation correcte
2019-02-12Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation correc
2019-02-12Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuati
2019-02-12Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected
2019-01-19Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vas
2018-12-28GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Produ
2018-12-20GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device
2018-11-30System, Tomography Computed Emmission
2018-11-30System, Tomography Computed Emmission
2018-11-15Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance ima
2018-11-09Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 S
2018-10-11Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammogr
2018-10-11Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical imag
2018-10-05GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b)
2018-09-27Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGL
2018-09-27Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPG
2018-09-27Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE
2018-09-25Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded War
2018-09-25Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: C
2018-09-25Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer
2018-09-25Panda Wall Mount warmer. Infant radiant warmer
2018-09-25Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer a
2018-09-25Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Care
2018-09-14GE Healthcare Millennium MC
2018-09-14GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisitio
2018-09-14GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
2018-09-14GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified phy
2018-09-11PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable
2018-09-11B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to b
2018-09-11B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be
2018-09-11PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40
2018-09-11B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring an
2018-08-31Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatri
2018-08-31Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pedia
2018-08-31Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pe
2018-08-31Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pedia
2018-08-31Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatri
2018-08-31Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatri
2018-08-30Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and
2018-07-12Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardia
2018-05-24Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e.
2018-05-24CT Goldseal BrightSpeed 16 PWR TIO 2 YR
2018-05-24Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
2018-05-24CT Goldseal Optima CT 600
2018-05-24Discovery NM/CT 670 Pro, model 5376204-70-54
2018-05-24Discovery RT labeled as: a. MID BJG; b. HVY BJG
2018-05-24Discovery NM/CT 670 ES, model 5376204-70-57
2018-05-24Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
2018-05-24Optima CT 520
2018-05-24Revolution CT 160 1.5D STD WAUK
2018-05-24Optima CT 540
2018-05-24Discovery MI Digital Ready
2018-05-24Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing o
2017-12-15Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Int
2017-12-15Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG
2017-10-30VariCam
2017-10-30Discover VH/Millennium VG Nuclear Medicine Imaging System
2017-10-04DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic ag
2017-10-04DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalatio
2017-05-19GE Healthcare Optima CT660, CT680 X-ray system
2017-05-19GE Healthcare Discovery IQ X-ray system
2017-05-19GE Healthcare Revolution EVO X-ray system
2017-05-19GE Healthcare Optima CT520 X-ray system
2017-05-19GE Healthcare BrightSpeed X-ray system
2017-05-19GE Healthcare Discovery NM/CT 570c X-ray system
2017-05-19GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system
2017-05-19GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system
2017-05-19GE Healthcare lnnova IGS 540 ACT X-ray system
2017-05-19GE Healthcare Optima CT540 X-ray system
2017-05-19GE Healthcare Discovery Ml X-ray system
2017-05-19GE Healthcare Lightspeed RT16 X-ray system
2017-05-19GE Healthcare LightSpeed VCT X-ray system
2017-05-19GE Healthcare Discovery NM/CT 670 CZT X-ray system
2017-05-19GE Healthcare Discovery Ml DR X-ray system
2017-05-19GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system
2017-05-05Infant Warmer System (IWS)
2017-05-02Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
2017-03-10Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
2017-03-10Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
2017-02-06Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
2017-01-20Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high res
2016-11-21Legacy
2016-11-21SFX
2016-11-21ADVANTX LCN+
2016-11-21RFX
2016-11-21ADVANTX LCV+
2016-11-21Precision 500D
2016-11-21Prestilix
2016-11-21ADVANTX LCA
2016-11-21Prestige II
2016-11-21ADVANTX LCLP+
2016-11-21Innova 2000
2016-11-21Prestige VH
2016-11-21Prestige SI
2016-11-03GE Healthcare, Avance, Avance CS2, Amingo.
2016-09-16Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
2016-08-31GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
2016-08-04Infant Warmer System (IWS)
2016-06-08GE Healthcare, Discovery MR750w
2016-05-09GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed T
2016-05-09Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
2016-05-09MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
2014-10-14Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA,
2014-10-14Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is inte
2014-10-14GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508P
2014-10-14Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H
2014-10-14GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia I
2014-10-14Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3
2014-09-19GE Healthcare Carescape Patient Data Module
2014-09-05GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray Sys
2014-09-04Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscop
2014-09-04Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular ang
2014-09-04Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic
2014-08-08CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas
2014-07-25GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic image
2014-07-07GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multipl
2014-06-13GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
2014-06-11DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L
2014-06-04GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiogra
2014-06-04GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiograp
2014-05-23GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Date
2014-05-02Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT
2014-04-23GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM o
2014-04-09GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-
2014-04-07GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis softwa
2014-04-02GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w
2014-03-27GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac i
2014-02-28GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The
2014-02-14GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discov
2014-02-13GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the
2014-02-07GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system
2014-02-07Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The int
2014-02-07GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle
2014-01-20GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR
2013-12-27GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a mu
2013-12-20CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple a
2013-12-16SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient D
2013-12-12GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 50
2013-12-11GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ,
2013-12-05GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intend
2013-12-05GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is
2013-12-05SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient D
2013-11-27GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
2013-11-27GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide u
2013-11-20GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery
2013-11-15GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usa
2013-11-08Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems:
2013-11-07GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numb
2013-10-25GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discove
2013-10-11HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K12225
2013-10-11GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is prim
2013-10-09GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sect
2013-10-01GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitat
2013-10-01GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant warmers pro
2013-10-01GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resus
2013-09-19Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs,
2013-09-19AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPT
2013-09-16GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control venti
2013-08-30GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnos
2013-08-28GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressu
2013-08-16GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova
2013-08-13GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designe
2013-08-07GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices
2013-07-29Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus
2013-06-19GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems
2013-06-13GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar syste
2013-06-13Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The i
2013-06-13Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage
2013-06-13Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear M
2013-06-13Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage:
2013-06-13GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for
2013-06-13Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage:
2013-05-14Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to
2013-05-09GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the follo
2013-05-02GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic
2013-04-10The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combinatio
2013-04-09GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2
2013-04-03GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is int
2013-04-03GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system i
2013-04-03SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient D
2013-03-28Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of
2013-03-28MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce
2013-03-26GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Pos
2013-03-26GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction
2013-02-08GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revis
2013-01-21GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova410
2013-01-14GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmograp
2013-01-09Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The
2013-01-08Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Health
2012-11-09GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasoun
2012-10-15Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, e
2012-10-15GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ve
2012-10-12GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appr
2012-09-26GE Healthcare Definium 5000 / 5220493 X-Ray System
2012-09-26GE Healthcare Definium 5000/5220493-2 X-Ray System
2012-09-20GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 51836
2012-09-20GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and bo
2012-09-20GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
2012-09-20GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of
2012-09-20GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
2012-08-16GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innov
2012-08-13GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician
2012-08-07GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for u
2012-08-03GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
2012-08-01GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series:
2012-08-01GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: B
2012-08-01GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series:
2012-07-20CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acu
2012-07-13GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general
2012-07-12GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient moni
2012-07-10Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
2012-07-10Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
2012-06-28GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows mult
2012-06-26GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use und
2012-06-26GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Di
2012-06-13GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
2012-06-13GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismou
2012-06-12GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 20
2012-06-08GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
2012-06-08GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa P
2012-06-08GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa
2012-05-29Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to v
2012-05-25GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Wor
2012-05-24GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2
2012-05-24AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 51600
2012-05-24GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Naviga
2012-05-24GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.
2012-05-24GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical i
2012-04-23GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated
2012-04-12GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI systems is a se
2012-04-10GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthe
2012-04-04GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended
2012-03-27GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
2012-03-06GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Vari
2012-02-17GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pr
2012-02-07GE Healthcare, LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM with R1.1.0 Software. Intended for use by a q
2012-01-23VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 452
2012-01-11GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by appropria
2012-01-11GE Discovery NM/CT 670 The GE Discovery NM/CT 670 system is a medical tool intended for use by appr
2012-01-04GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Mod
2012-01-03GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. The device i
2011-12-23GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200
2011-12-23GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for the eval
2011-12-20GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in gener
2011-12-20GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in gene
2011-12-20GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innov
2011-12-20GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in genera
2011-12-15GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when integrated
2011-11-22GE Healthcare Definium 8000, Digital Radiographic Systems. Revolution XR/d Digital Radiographic Im
2011-11-22GE Healthcare Discovery XR650, Digital Radiographic Systems. Revolution XR/d Digital Radiographic
2011-11-21SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYS
2011-11-17GE Healthcare AW Server version 2.0 with release 2.0 - 4.0 A medical software system that allows m
2011-10-26REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS The Revolution XR/d with Tom
2011-10-21GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imag
2011-10-17GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D syste
2011-10-06GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and c
2011-09-30GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient moni
2011-09-22GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL). The Senographe Essential sy
2011-09-22GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS system generate
2011-09-15GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T
2011-08-29GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. The MSK Extreme TM MR Scanner is intended
2011-08-24GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicated for use
2011-08-18ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module tha
2011-07-29GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750) Product Usage: The GE Sigma M
2011-07-29GE Healthcare, 1.5T Optima MR450w Product Usage: The Optima MR450w is a whole body magnetic reson
2011-07-29GE Healthcare, Discovery MR450 Product Usage: The Discovery MR450w is a whole body magnetic resona
2011-07-25GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT7
2011-07-20GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional hea
2011-07-05GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors The Dash 3000/4000/5000 patient monitor is in
2011-05-31GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000
2011-05-16GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indi
2011-05-10Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, an
2011-05-04GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated fo
2011-04-26Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus
2011-04-08DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare)
2011-04-05GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to p
2011-03-25GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 534
2011-03-23GE Healthcare, CARESCAPE Monitor B850 The CARESCAPE Monitor B650 is a multi-parameter patient monit
2011-03-23GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monit
2011-03-08GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a hi
2011-03-04Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc. A pressure infusor
2011-02-04GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems.
2011-01-31GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or othe
2011-01-28GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use under the
2011-01-26GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
2011-01-19GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential sys
2011-01-19BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Co
2011-01-12Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 The display, processing, archiving, an
2010-11-24GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 Advantage Sim MD is use
2010-11-18GE Healthcare, Optima MR450w 1.5T MR systems The GE Signa MR750 System is a whole body magnetic reso
2010-11-18GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a whole body magnetic resonance scan
2010-11-18GE Healthcare Discovery MR450 1.5T, The Discovery MR450 is a whole body magnetic resonance scanner
2010-11-099) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Sig
2010-11-0910) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330) T
2010-11-091) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for
2010-11-096) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa Excite 1.5T an
2010-11-098) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System)
2010-11-093) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is
2010-11-092) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device
2010-11-094) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole body ma
2010-11-097) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa
2010-11-095) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa H
2010-10-27GE Discovery ST (16 Slice) System; Discovery ST (16 Slice) Systems with technical Reference Manual n
2010-10-27GE Healthcare STe (16 slice) System; Discovery STe (16 Slice) Systems with technical Reference Manua
2010-10-27XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION The display, processing, archiving,
2010-10-27GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with tec
2010-10-27GE Healthcare Discovery LS (16 slice) System; Discovery LS (16 Slice) Systems with technical Referen
2010-10-27LightSpeed 16 Computed Tomography X-ray Systems; LightSpeed 16 Computed Tomography X-ray Systems wit
2010-10-11Power supply boards on Dash 3000, 4000 and 5000 Monitors. GE Healthcare, 8200 West Tower Avenue, Mil
2010-10-05GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module.
2010-09-03GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5
2010-09-03GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry
2010-08-30GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE,
2010-08-30GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE,
2010-08-30GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE,
2010-08-23Signa OpenSpeed, 0.7T MR Systems (HFO3-5).
2010-08-23Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging device to prod
2010-07-20GE SENOGRAPHE DS FULL FIELD MAMMOGRAPHY SYSTEM MAMMOGRAPHIC FILM / SCREEN SYSTEM
2010-07-20GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this
2010-07-16CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patie
2010-06-25DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (inclu
2010-06-10Innova 2000, manufactured by GE Medical Systems, SCS
2010-06-10Precision 500D X-ray systems with under-table collimator part number 5234960. The Precision 500D i
2010-06-03Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images
2010-06-03Innova 4100/4100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic
2010-06-03Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic
2010-05-06GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE " Moni
2010-05-01BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Co
2010-04-29DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
2010-03-24GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane pos
2010-03-24GE Healthcare, Innova 3100 IQ : GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system
2010-03-24GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system
2010-03-12GE, 1009-9002-000 Avance Anesthesia Machine and Monitor
2010-03-12GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
2010-02-09GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno Advantage
2010-02-01HiSpeed FX/I (2200997 with Gantry mo. #2249696)
2010-02-01HiSpeed FX/I (2200997 with Gantry mo. #2249696-2)
2010-02-01HiSpeed FX/I (2200997 with Gantry mo. #2200997-2)
2010-02-01HiSpeed FX/I (2200997 with Gantry mo. #2201000-2)
2010-02-01HiSpeed LX/l (2200997-2)
2010-02-01HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2)
2010-02-01HiSpeed LXI (2200997)
2010-02-01HiSpeed DX/I (2201000)
2010-02-01HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2)
2010-02-01HiSpeed DX/I (2201000-2)
2010-02-01HiSpeed FX/I (2201000-2 with Gantry mo. #2201000-2)
2010-02-01HiSpeed FX/I (2200997 with Gantry mo. #2201000)
2010-02-01HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2)
2010-02-01HiSpeed FX/I (2200997-2 with Gantry mo. #2200997)
2010-02-01HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2)
2010-02-01Hi Speed DX/I (2249696-2)
2010-02-01HiSpeed FX/I (2201000-2 with Gantry mo. #2200997)
2010-02-01HiSpeed FX/I (2201000-2 with Gantry mo. #2201000)
2010-02-01HiSpeed FX/I (2200997 with Gantry mo. #2200997)
2010-02-01HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2)
2010-02-01HiSpeed DX/I (2249696)
2010-02-01HiSpeed FX/I (2201000-2 with Gantry mo. #2249696)
2010-02-01HiSpeed FX/I (2200997-2 with Gantry mo. #2201000)
2010-02-01HiSpeed FX/I (2200997-2 with Gantry mo. #2249696)
2009-08-28GE Healthcare IDI Mammo Workstation
2009-08-28GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1
2009-08-06Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consis
2009-08-06Innova 2000 The principle system components include a C-arm, image acquisition, processing and archi
2009-08-05Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consis
2009-08-05Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha,
2009-08-05Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vasc
2009-08-05Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the fi
2009-05-11Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwauke
2009-03-24Definium 5000 X-ray System, model number 5220493 and 5220393-2
2009-02-02GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardi