PlainRecalls

GE Healthcare, LLC

324 recalls on record · Latest: Aug 31, 2022

GE Healthcare, LLC Recall Insight

GE Healthcare, LLC appears on 324 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.386% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Aug 31, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 48 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from May 6, 2020 to Oct 27, 2021.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Oct 27, 2021

SIGNA Architect nuclear magnetic resonance imaging system

FDA Devices Moderate Oct 27, 2021

SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

FDA Devices Moderate Oct 27, 2021

Discovery MR750w 3.0T nuclear magnetic resonance imaging system

FDA Devices Moderate Oct 27, 2021

SIGNA Voyager nuclear magnetic resonance imaging system

FDA Devices Moderate Oct 27, 2021

SIGNA Artist nuclear magnetic resonance imaging system

FDA Devices Moderate Oct 27, 2021

Discovery MR750 3.0T nuclear magnetic resonance imaging system

FDA Devices Moderate Oct 6, 2021

Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva…

FDA Devices Moderate Sep 29, 2021

Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various ima…

FDA Devices Moderate Sep 29, 2021

Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imagi…

FDA Devices Moderate Aug 4, 2021

CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

FDA Devices Moderate Jul 21, 2021

SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short …

FDA Devices Moderate Jul 21, 2021

SIGNA Artist, Nuclear Magnetic Resonance Imaging System

FDA Devices Moderate Jul 21, 2021

SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

FDA Devices Moderate Jul 21, 2021

Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, an…

FDA Devices Moderate Jul 21, 2021

1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System

FDA Devices Moderate Jul 21, 2021

Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

FDA Devices Moderate Jul 21, 2021

SIGNA MR380, Nuclear Magnetic Resonance Imaging System

FDA Devices Moderate Jul 14, 2021

The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles …

FDA Devices Moderate Jul 14, 2021

Revolution CT

FDA Devices Moderate Jul 7, 2021

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

FDA Devices Moderate Jun 23, 2021

GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840…

FDA Devices Moderate May 19, 2021

NM/CT 860 Nuclear Medicine / CT Scanners

FDA Devices Moderate Feb 24, 2021

System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.

FDA Devices Moderate Feb 17, 2021

GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor…

FDA Devices Moderate Jan 20, 2021

GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope …

FDA Devices Moderate Jan 20, 2021

Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for gen…

FDA Devices Moderate Jan 20, 2021

Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Prod…

FDA Devices Moderate Jan 20, 2021

GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…

FDA Devices Moderate Jan 20, 2021

GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…

FDA Devices Moderate Jan 20, 2021

Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer …

FDA Devices Moderate Dec 30, 2020

Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

FDA Devices Moderate Dec 30, 2020

Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

FDA Devices Moderate Dec 16, 2020

MAC VU360, Electrocardiograph

FDA Devices Moderate Nov 11, 2020

Flow Sensor Service Part, Catalog 2089610-001-S

FDA Devices Moderate Nov 11, 2020

Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional …

FDA Devices Moderate Nov 11, 2020

9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

FDA Devices Moderate Nov 11, 2020

GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide ran…

FDA Devices Moderate Nov 11, 2020

Flow Sensor Service Part, Catalog 2096513-001-S

FDA Devices Moderate Nov 4, 2020

Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular …

FDA Devices Moderate Oct 28, 2020

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign…

FDA Devices Moderate Sep 30, 2020

NM/CT 850 Model Number: H3907AD

FDA Devices Moderate Sep 30, 2020

Discovery NM 630 Model # H3101RH

FDA Devices Moderate Sep 30, 2020

Discovery NM670 Pro Model # H3100XB

FDA Devices Moderate Aug 12, 2020

CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-par…

FDA Devices Moderate Jul 1, 2020

CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042…

FDA Devices Moderate Jun 24, 2020

Giraffe Incubator with installed Servo Oxygen module. Infant incubator.

FDA Devices Moderate Jun 24, 2020

Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.

FDA Devices Moderate Jun 10, 2020

System, Tomography Computed Emmission

FDA Devices Moderate Jun 3, 2020

Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.

FDA Devices Moderate May 6, 2020

Lunar iDXA bone densitometer

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds