Medical DeviceNov 11, 2020
GE Healthcare Flow Sensor Service Part, Catalog 2096513-001-S recall — FDA Z-0317-2021
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Class IIFDA: OngoingGE Healthcare, LLC
Recall history in this database
Classification mix: Class II: 236, Class I: 17, Class III: 6.
Medical DeviceNov 11, 2020
GE Healthcare Flow Sensor Service Part, Catalog 2087640-001-S recall — FDA Z-0316-2021
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceNov 11, 2020
GE Healthcare GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to recall — FDA Z-0313-2021
Flow sensors could have damaged tubes in the form of small punctures or cuts.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceNov 4, 2020
GE Healthcare Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product recall — FDA Z-0306-2021
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceOct 28, 2020
GE Healthcare System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body recall — FDA Z-0130-2021
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceOct 28, 2020
GE Healthcare System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body recall — FDA Z-0127-2021
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceOct 28, 2020
GE Healthcare System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body recall — FDA Z-0129-2021
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceOct 28, 2020
GE Healthcare System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body recall — FDA Z-0128-2021
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceOct 28, 2020
GE Healthcare Tomographic Imager Combining Emission Computed Tomography With Nuclear recall — FDA Z-0131-2021
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceSep 2, 2020
GE Healthcare CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor recall — FDA Z-2883-2020
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.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceAug 12, 2020
GE Healthcare CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a recall — FDA Z-2750-2020
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.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJul 1, 2020
GE Healthcare CARESCAPE Patient Data Module (PDM) used with the following monitors recall — FDA Z-2424-2020
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…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 24, 2020
GE Healthcare Giraffe Incubator with installed Servo Oxygen module recall — FDA Z-2236-2020
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…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 24, 2020
GE Healthcare Giraffe OmniBed with installed Servo Oxygen module recall — FDA Z-2235-2020
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…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJun 10, 2020
GE Healthcare System, Tomography Computed Emmission recall — FDA Z-2258-2020
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…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 10, 2020
GE Healthcare System, Tomography Computed Emmission recall — FDA Z-2259-2020
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…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 3, 2020
GE Healthcare Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 recall — FDA Z-2111-2020
During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceMay 6, 2020
GE Healthcare Lunar iDXA bone densitometer recall — FDA Z-1709-2020
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceMay 6, 2020
GE Healthcare Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer recall — FDA Z-1710-2020
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceMay 6, 2020
GE Healthcare Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer recall — FDA Z-1712-2020
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceMay 6, 2020
GE Healthcare Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer recall — FDA Z-1711-2020
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceFeb 5, 2020
GE Healthcare SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is recall — FDA Z-0875-2020
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…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceFeb 5, 2020
GE Healthcare SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a recall — FDA Z-0876-2020
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…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceFeb 5, 2020
GE Healthcare SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a recall — FDA Z-0874-2020
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…
Class IIFDA: TerminatedGE Healthcare, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies GE Healthcare, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.