PlainRecalls

Ge Healthcare LLC

Compiled from official public sources by the publisher.

475 recalls on record · Latest: Apr 8, 2026

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Agency notice ledger

Federal filing book Ge Healthcare LLC HEAVY-BOOK · SINGLE-AGENCY

#14 of 14,151 · 475 notices · 0.455% archive

  • BOOK 475 notices
  • RANK #14 of 14,151
  • SHARE 0.455% archive
  • AGENCY FDA Devices (475)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 8, 2026
  • PHOTO Arrow International I…

Nearest notice-volume peer: Arrow International Inc. (3 notice gap)

Ge Healthcare LLC accounts for about 0.455% of the 104,423-notice archive on 475 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Ge Healthcare LLC compares to 14,151 recalling firms

Ge Healthcare LLC ranks 14th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Ge Healthcare LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

475 14th of 14151 higher than 14,137 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14

Ge Healthcare LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Ge Healthcare LLC holds about 0.455% of archive notices alongside 475 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jun 21, 2017

GE Healthcare Revolution EVO X-ray system
FDA Devices Moderate Jun 21, 2017

GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system
FDA Devices Moderate Jun 7, 2017

Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
FDA Devices Moderate Apr 19, 2017

Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
FDA Devices Moderate Apr 19, 2017

Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
FDA Devices Moderate Feb 22, 2017

Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps. and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostat
FDA Devices Moderate Jan 18, 2017

Infant Warmer System (IWS)
FDA Devices Moderate Jan 4, 2017

Prestige VH
FDA Devices Moderate Jan 4, 2017

Precision 500D
FDA Devices Moderate Jan 4, 2017

ADVANTX LCA
FDA Devices Moderate Jan 4, 2017

Prestige SI
FDA Devices Moderate Jan 4, 2017

RFX
FDA Devices Moderate Jan 4, 2017

ADVANTX LCV+
FDA Devices Moderate Jan 4, 2017

Prestilix
FDA Devices Moderate Jan 4, 2017

Innova 2000
FDA Devices Moderate Jan 4, 2017

Legacy
FDA Devices Moderate Jan 4, 2017

ADVANTX LCLP+
FDA Devices Moderate Jan 4, 2017

ADVANTX LCN+
FDA Devices Moderate Jan 4, 2017

SFX
FDA Devices Moderate Jan 4, 2017

Prestige II
FDA Devices Moderate Dec 21, 2016

GE Healthcare, Avance, Avance CS2, Amingo.
FDA Devices Moderate Sep 14, 2016

GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
FDA Devices Moderate Jul 13, 2016

GE Healthcare, Discovery MR750w
FDA Devices Moderate Jun 15, 2016

GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
FDA Devices Moderate Jun 15, 2016

MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
FDA Devices Moderate Jun 15, 2016

Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
FDA Devices Moderate Dec 24, 2014

Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
FDA Devices Moderate Dec 24, 2014

Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
FDA Devices Moderate Dec 24, 2014

Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
FDA Devices Moderate Nov 19, 2014

Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer
FDA Devices Moderate Nov 19, 2014

Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disord
FDA Devices Moderate Nov 19, 2014

Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
FDA Devices Moderate Nov 19, 2014

Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended fo
FDA Devices Moderate Nov 19, 2014

GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK. Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Me
FDA Devices Moderate Nov 19, 2014

GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinic
FDA Devices Moderate Oct 15, 2014

GE Healthcare Carescape Patient Data Module
FDA Devices Moderate Oct 8, 2014

GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
FDA Devices Moderate Sep 17, 2014

CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor
FDA Devices Moderate Aug 27, 2014

GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
FDA Devices Critical Jul 30, 2014

DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Devices Moderate Jul 30, 2014

GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Devices Moderate Jul 30, 2014

GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
FDA Devices Moderate Jul 9, 2014

GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Devices Moderate Jul 9, 2014

GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Devices Moderate Jun 25, 2014

GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Devices Moderate Jun 11, 2014

Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, th
FDA Devices Moderate May 28, 2014

GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
FDA Devices Moderate May 7, 2014

GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.
FDA Devices Moderate May 7, 2014

GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.
FDA Devices Moderate Apr 30, 2014

GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.

Ge Healthcare LLC carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (475 here — heavy-book).

Arrow International Inc. 478 Attix Pharmaceuticals 470 King Bio Inc. 465 Medline Industries, LP 486 Zimmer, Inc. 446

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Arrow International Inc. 478 Medline Industries, LP 486 Zimmer, Inc. 446 B Braun Medical Inc 444

Frequently Asked Questions

How many federal recall notices name Ge Healthcare LLC? ▼
PlainRecalls indexes 475 distinct federal recall events naming Ge Healthcare LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Ge Healthcare LLC sit among other recalling firms? ▼
Ge Healthcare LLC ranks #14 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Ge Healthcare LLC's notices? ▼
FDA Devices accounts for 475 of this firm's 475 indexed notices.
What product category dominates Ge Healthcare LLC's filing book? ▼
Filings for Ge Healthcare LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Ge Healthcare LLC: 475 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Ge Healthcare LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026