Recall archive
153 recalls · page 2 of 7
Reported Jun 30, 2021
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an…
FDA (openFDA device enforcement)
Reported Jun 23, 2021
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two…
FDA (openFDA device enforcement)
Reported May 19, 2021
NM/CT 850 Nuclear Medicine / CT Scanners
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 12, 2021
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist…
FDA (openFDA device enforcement)
Reported Feb 24, 2021
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A…
FDA (openFDA device enforcement)
Reported Jan 20, 2021
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 30, 2020
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 16, 2020
MAC VU360, Electrocardiograph
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Incorrect patient identification and/or patient demographic errors.
FDA (openFDA device enforcement)
Reported Nov 11, 2020
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Flow sensors could have damaged tubes in the form of small punctures or cuts.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 4, 2020
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
FDA (openFDA device enforcement)
Reported Oct 28, 2020
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2020
NM/CT 850 Model Number: H3907AD
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Rotor bearing screws were found loose on detector.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2020
CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being…
FDA (openFDA device enforcement)
Reported Aug 12, 2020
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product details — CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to…
FDA (openFDA device enforcement)
Reported Jul 1, 2020
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace…
FDA (openFDA device enforcement)
Reported Jun 24, 2020
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2020
System, Tomography Computed Emmission
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2020
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
FDA (openFDA device enforcement)
Reported May 6, 2020
Lunar iDXA bone densitometer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2020
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2020
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2020
CARESCAPE Respiratory Module E-sCO
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand — Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2020
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product details — When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro…
2 more products in this recall
FDA (openFDA device enforcement)
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