GE Healthcare Recalls
567 recalls on record · June 27, 2012 to April 8, 2026 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 14, 2021Medical DevicesFDA
GE Healthcare, LLC recalls The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission da
Hazard: When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
July 14, 2021Medical DevicesFDA
GE Healthcare, LLC recalls The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission pr
Hazard: When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
July 14, 2021Medical DevicesFDA
GE Healthcare, LLC recalls The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission pr
Hazard: When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
July 14, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Revolution CT
Hazard: GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
July 7, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Hazard: Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
June 30, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG applica
Hazard: 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 Electronic Medical Record (EMR) or a similar system.
June 23, 2021Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614)
Hazard: The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.
May 19, 2021Medical DevicesFDA
GE Healthcare, LLC recalls NM/CT 870 DR Nuclear Medicine / CT Scanners
Hazard: 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 compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
May 19, 2021Medical DevicesFDA
GE Healthcare, LLC recalls NM/CT 860 Nuclear Medicine / CT Scanners
Hazard: 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 compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
May 19, 2021Medical DevicesFDA
GE Healthcare, LLC recalls NM/CT 850 Nuclear Medicine / CT Scanners
Hazard: 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 compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
May 12, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, an
Hazard: When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s).
February 24, 2021Medical DevicesFDA
GE Healthcare, LLC recalls System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Hazard: GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
February 24, 2021Medical DevicesFDA
GE Healthcare, LLC recalls System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Hazard: GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
February 17, 2021Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use
Hazard: GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient or operator.
January 20, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for dete
Hazard: 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 rotor bearings in the detector.
January 20, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery
Hazard: 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 rotor bearings in the detector.
January 20, 2021Medical DevicesFDA
GE Healthcare, LLC recalls Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Pr
Hazard: 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 rotor bearings in the detector.
January 20, 2021Medical DevicesFDA
GE Healthcare, LLC recalls GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures f
Hazard: 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 rotor bearings in the detector.
January 20, 2021Medical DevicesFDA
GE Healthcare, LLC recalls GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for d
Hazard: 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 rotor bearings in the detector.
January 20, 2021Medical DevicesFDA
GE Healthcare, LLC recalls GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for d
Hazard: 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 rotor bearings in the detector.
December 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Com
Hazard: A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
December 30, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applicat
Hazard: A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
December 16, 2020Medical DevicesFDA
GE Healthcare, LLC recalls MAC VU360, Electrocardiograph
Hazard: Incorrect patient identification and/or patient demographic errors.
November 11, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Flow Sensor Service Part, Catalog 2096513-001-S
Hazard: Flow sensors could have damaged tubes in the form of small punctures or cuts.
November 11, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Flow Sensor Service Part, Catalog 2087640-001-S
Hazard: Flow sensors could have damaged tubes in the form of small punctures or cuts.
November 11, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Flow Sensor Service Part, Catalog 2089610-001-S
Hazard: Flow sensors could have damaged tubes in the form of small punctures or cuts.
November 11, 2020Medical DevicesFDA
GE Healthcare, LLC recalls 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Hazard: Flow sensors could have damaged tubes in the form of small punctures or cuts.
November 11, 2020Medical DevicesFDA
GE Healthcare, LLC recalls GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ve
Hazard: Flow sensors could have damaged tubes in the form of small punctures or cuts.
November 11, 2020Medical DevicesFDA
GE Healthcare, LLC recalls GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and vent
Hazard: Flow sensors could have damaged tubes in the form of small punctures or cuts.
November 11, 2020Medical DevicesFDA
GE Healthcare, LLC recalls Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set
Hazard: Flow sensors could have damaged tubes in the form of small punctures or cuts.