RecallHawk

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

GE Healthcare, LLC

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

GE Healthcare, LLC

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

GE Healthcare, LLC

Centricity Cardiology CA1000

GE Healthcare, LLC

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

GE Healthcare, LLC

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

GE Healthcare, LLC

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

GE Healthcare, LLC

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

GE Healthcare, LLC

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

GE Healthcare, LLC

GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System,

GE Healthcare, LLC

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

GE Healthcare, LLC

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance

GE Healthcare, LLC

GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance im

GE Healthcare, LLC

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

GE Healthcare, LLC

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

GE Healthcare, LLC

GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imag

GE Healthcare, LLC

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

GE Healthcare, LLC

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

GE Healthcare, LLC

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

GE Healthcare, LLC

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining

GE Healthcare, LLC

GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.

GE Healthcare, LLC

GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"

GE Healthcare, LLC

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"

GE Healthcare, LLC

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; (

GE Healthcare, LLC

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