GE Healthcare Recalls
567 recalls on record · June 27, 2012 to April 8, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 4, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whol
Hazard: There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
October 28, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined
Hazard: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
October 28, 2020Medical DevicesFDA
GE Healthcare, LLC recalls System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to suppo
Hazard: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
October 28, 2020Medical DevicesFDA
GE Healthcare, LLC recalls System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to suppo
Hazard: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
October 28, 2020Medical DevicesFDA
GE Healthcare, LLC recalls System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to suppo
Hazard: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
October 28, 2020Medical DevicesFDA
GE Healthcare, LLC recalls System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to suppo
Hazard: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
September 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls NM/CT 870 DR Model # H3100AS
Hazard: Rotor bearing screws were found loose on detector.
September 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Discovery NM670 Pro Model # H3100XB
Hazard: Rotor bearing screws were found loose on detector.
September 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Discovery 670 DR Model # H3100BT
Hazard: Rotor bearing screws were found loose on detector.
September 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls NM 830 Model # H3910AC
Hazard: Rotor bearing screws were found loose on detector.
September 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Discovery NM 630 Model # H3101RH
Hazard: Rotor bearing screws were found loose on detector.
September 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls NM/CT 870 CZT Model # H3906CW
Hazard: Rotor bearing screws were found loose on detector.
September 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls NM/CT 860, SPECT/CT
Hazard: Rotor bearing screws were found loose on detector.
September 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls NM/CT 850 Model Number: H3907AD
Hazard: Rotor bearing screws were found loose on detector.
September 9, 2020Medical DevicesFDA
Ge Healthcare recalls The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical a
Hazard: GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.
September 2, 2020Medical DevicesFDA
GE Healthcare, LLC recalls CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumat
Hazard: 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 delivered.
August 12, 2020Medical DevicesFDA
GE Healthcare, LLC recalls CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor an
Hazard: 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 a CARESCAPE B450/B650/B850 host monitor.
July 1, 2020Medical DevicesFDA
GE Healthcare, LLC recalls CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transp
Hazard: The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.
June 24, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Hazard: Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
June 24, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Hazard: Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
June 10, 2020Medical DevicesFDA
GE Healthcare, LLC recalls System, Tomography Computed Emmission
Hazard: GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
June 10, 2020Medical DevicesFDA
GE Healthcare, LLC recalls System, Tomography Computed Emmission
Hazard: GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
June 3, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Hazard: During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
May 6, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
Hazard: An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
May 6, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
Hazard: An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
May 6, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
Hazard: An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
May 6, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Lunar iDXA bone densitometer
Hazard: An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
February 5, 2020Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is
Hazard: 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 setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
February 5, 2020Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner desi
Hazard: 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 setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
February 5, 2020Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner de
Hazard: 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 setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.