GE Healthcare, LLC
104 FDA actions
SIGNA Premier systems
GE Healthcare LLC
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3
GE Healthcare, LLC
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Cap
GE Healthcare, LLC
Centricity PACS Software Version 7.0 SP0.0.4.7
GE Healthcare, LLC
SIGNA Premier magnetic resonance scanner, model 5748519.
GE Healthcare, LLC
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia Syste
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GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part
GE Healthcare, LLC
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data with
GE Healthcare, LLC
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
GE Healthcare, LLC
Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo
GE Healthcare, LLC
CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU an
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Centricity Radiology RA600
GE Healthcare, LLC
Centricity Universal Viewer Zero Footprint Client
GE Healthcare, LLC
Centricity Enterprise Web
GE Healthcare, LLC
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engst
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Centricity Cardiology CA1000
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Centricity PACS RA1000
GE Healthcare, LLC
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116)
GE Healthcare, LLC
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery
GE Healthcare, LLC
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
GE Healthcare, LLC
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
GE Healthcare, LLC
SIGNA Excite 3T. Magnetic Resonance Imaging System
GE Healthcare, LLC
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
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Revolution Apex, Revolution CT with Apex Edition
GE Healthcare, LLC
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
GE Healthcare, LLC
Revolution CT, Revolution CT ES
GE Healthcare, LLC
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082
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GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance i
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic
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GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition s
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonanc
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GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resona
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GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System,
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GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR Syste
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GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance
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GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance im
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GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuc
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic res
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magne
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GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnet
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GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imag
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GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance sy
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic res
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GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic reson
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic re
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GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance
GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imagin
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GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining
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GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.
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GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
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GE Vscan Extend, being sold as "Vscan Extend Dual USB"
GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Console"
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GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
GE Healthcare, LLC
GE Centricity Universal Viewer Zero Footprint Client
GE Healthcare, LLC
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
GE Healthcare, LLC
SIGNA Pioneer nuclear magnetic resonance imaging system
GE Healthcare, LLC
Optima MR450w 1.5T nuclear magnetic resonance imaging system
GE Healthcare, LLC
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
GE Healthcare, LLC
SIGNA Architect nuclear magnetic resonance imaging system
GE Healthcare, LLC
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
GE Healthcare, LLC
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
GE Healthcare, LLC
SIGNA Voyager nuclear magnetic resonance imaging system
GE Healthcare, LLC
SIGNA Artist nuclear magnetic resonance imaging system
GE Healthcare, LLC
Discovery MR750 3.0T nuclear magnetic resonance imaging system
GE Healthcare, LLC
SIGNA Premier nuclear magnetic resonance imaging system
GE Healthcare, LLC
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
GE Healthcare, LLC
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (
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AMX Navigate Mobile X-Ray System
GE Healthcare, LLC
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSO
GE Healthcare, LLC
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammogra
GE Healthcare, LLC
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms
GE Healthcare, LLC
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
GE Healthcare, LLC
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign
GE Healthcare, LLC
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
GE Healthcare, LLC
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, h
GE Healthcare, LLC
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
SIGNA MR380, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, hi
GE Healthcare, LLC
SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high si
GE Healthcare, LLC
SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign
GE Healthcare, LLC
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
GE Healthcare, LLC
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission da
GE Healthcare, LLC
Revolution CT
GE Healthcare, LLC
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission pr
GE Healthcare, LLC
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission pr
GE Healthcare, LLC
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
GE Healthcare, LLC