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.
October 27, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Optima MR450w 1.5T nuclear magnetic resonance imaging system
Hazard: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
October 27, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Artist nuclear magnetic resonance imaging system
Hazard: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
October 27, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Voyager nuclear magnetic resonance imaging system
Hazard: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
October 27, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Hazard: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
October 27, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Discovery MR750 3.0T nuclear magnetic resonance imaging system
Hazard: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
October 27, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Discovery MR750w 3.0T nuclear magnetic resonance imaging system
Hazard: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
October 27, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Pioneer nuclear magnetic resonance imaging system
Hazard: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
October 27, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Architect nuclear magnetic resonance imaging system
Hazard: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
October 27, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Premier nuclear magnetic resonance imaging system
Hazard: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
October 13, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Hazard: A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
October 6, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (
Hazard: The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
October 6, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSO
Hazard: The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
October 6, 2021Medical DevicesFDA
GE Healthcare, LLC recalls AMX Navigate Mobile X-Ray System
Hazard: An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
September 29, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammogra
Hazard: Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
September 29, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms
Hazard: Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
August 4, 2021Medical DevicesFDA
GE Healthcare, LLC recalls CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Hazard: Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Artist, Nuclear Magnetic Resonance Imaging System
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA MR380, Nuclear Magnetic Resonance Imaging System
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, hi
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, h
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high si
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
July 21, 2021Medical DevicesFDA
GE Healthcare, LLC recalls SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign
Hazard: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.