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GE Medical Systems Recalls
168 recalls on record · November 11, 2015 to July 22, 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.
March 19, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
March 19, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
March 19, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
March 19, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
March 19, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
March 19, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
February 12, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Optima XR646 HD. X-Ray imaging system.
Hazard: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
February 12, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery XR656 HD. X-Ray imaging system.
Hazard: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
February 12, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery XR656HD. X-Ray imaging system.
Hazard: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
February 12, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Hazard: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
January 22, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile
Hazard: There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
January 15, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Hazard: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
January 15, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
Hazard: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
January 15, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
Hazard: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
January 15, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Hazard: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
January 15, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610
Hazard: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
January 15, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3
Hazard: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
January 15, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3)
Hazard: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
January 15, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3)
Hazard: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
December 4, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVER
Hazard: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
December 4, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Hazard: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
December 4, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Hazard: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
December 4, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery MR750w 3.0T, whole body magnetic resonance scanner
Hazard: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
August 14, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use
Hazard: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
August 14, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
Hazard: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
August 14, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only
Hazard: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
August 14, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on
Hazard: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
August 14, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Hazard: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
August 14, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Hazard: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
August 14, 2024Medical DevicesFDA
GE Medical Systems, LLC recalls Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syste
Hazard: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.