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.
SIGNA Architect nuclear magnetic resonance imaging system
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
SIGNA Voyager nuclear magnetic resonance imaging system
SIGNA Artist nuclear magnetic resonance imaging system
Discovery MR750 3.0T nuclear magnetic resonance imaging system
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva…
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various ima…
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imagi…
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short …
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, an…
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
SIGNA MR380, Nuclear Magnetic Resonance Imaging System
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles …
Revolution CT
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840…
NM/CT 860 Nuclear Medicine / CT Scanners
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor…
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope …
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for gen…
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Prod…
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer …
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
MAC VU360, Electrocardiograph
Flow Sensor Service Part, Catalog 2089610-001-S
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional …
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide ran…
Flow Sensor Service Part, Catalog 2096513-001-S
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular …
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign…
NM/CT 850 Model Number: H3907AD
Discovery NM 630 Model # H3101RH
Discovery NM670 Pro Model # H3100XB
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-par…
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042…
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
System, Tomography Computed Emmission
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Lunar iDXA bone densitometer
Nearby Manufacturers
Other firms with recall activity tracked in the PlainRecalls index.
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