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 3 critical, 47 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 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 Mar 5, 2014 to Jun 21, 2017.

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 Jun 21, 2017

GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system

FDA Devices Moderate Jun 21, 2017

GE Healthcare Discovery Ml DR X-ray system

FDA Devices Moderate Jun 21, 2017

GE Healthcare Optima CT540 X-ray system

FDA Devices Moderate Jun 21, 2017

GE Healthcare Discovery IQ 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 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 Dec 21, 2016

GE Healthcare, Avance, Avance CS2, Amingo.

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 …

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 card…

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 c…

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 Disco…

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. …

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 proce…

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, H2401…

FDA Devices Moderate Oct 15, 2014

GE Healthcare Carescape Patient Data Module

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 uni…

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, ex…

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 MODUL…

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 prof…

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 gen…

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 purp…

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 fa…

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 in…

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 rel…

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 5…

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 equ…

FDA Devices Moderate Apr 30, 2014

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

FDA Devices Moderate Mar 26, 2014

GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Compu…

FDA Devices Moderate Mar 19, 2014

Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform gene…

FDA Devices Moderate Mar 19, 2014

GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging syste…

FDA Devices Moderate Mar 19, 2014

GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging p…

FDA Devices Moderate Mar 19, 2014

GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter pa…

FDA Devices Moderate Mar 12, 2014

GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled.…

FDA Devices Moderate Mar 12, 2014

GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW …

FDA Devices Moderate Mar 5, 2014

GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), wh…

FDA Devices Critical Mar 5, 2014

GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner t…

FDA Devices Critical Mar 5, 2014

GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag a…

Nearby Manufacturers

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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