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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.
December 28, 2022Medical DevicesFDA
GE Medical Systems, LLC recalls B125P Patient Monitor (with E-module slot option), REF 6160000-002
Hazard: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
December 28, 2022Medical DevicesFDA
GE Medical Systems, LLC recalls B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
Hazard: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
December 28, 2022Medical DevicesFDA
GE Medical Systems, LLC recalls Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imagin
Hazard: There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
December 28, 2022Medical DevicesFDA
GE Medical Systems, LLC recalls Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and dat
Hazard: There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
October 31, 2018Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex
Hazard: Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.
October 31, 2018Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed
Hazard: A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
October 31, 2018Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
Hazard: GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.
October 24, 2018Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHO
Hazard: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
October 24, 2018Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXC
Hazard: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
October 24, 2018Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T
Hazard: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
October 3, 2018Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product
Hazard: GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
August 1, 2018Medical DevicesFDA
GE Medical Systems, LLC recalls MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic reso
Hazard: There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patient to be moved from the GE MR Surgical Table to the Maquet Magnus Surgical Table.
August 23, 2017Medical DevicesFDA
GE Medical Systems, LLC recalls Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic device
Hazard: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
August 23, 2017Medical DevicesFDA
GE Medical Systems, LLC recalls 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa
Hazard: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
August 23, 2017Medical DevicesFDA
GE Medical Systems, LLC recalls 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Sig
Hazard: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
August 23, 2017Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonan
Hazard: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
August 23, 2017Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance
Hazard: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
August 23, 2017Medical DevicesFDA
GE Medical Systems, LLC recalls Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed
Hazard: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
August 23, 2017Medical DevicesFDA
GE Medical Systems, LLC recalls Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed t
Hazard: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
August 23, 2017Medical DevicesFDA
GE Medical Systems, LLC recalls Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners
Hazard: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
August 23, 2017Medical DevicesFDA
GE Medical Systems, LLC recalls Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner des
Hazard: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
June 1, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Hazard: Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.
June 1, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Hazard: Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure.
May 11, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applica
Hazard: An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
May 4, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wid
Hazard: The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient.
April 20, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Aisys Carestation.
Hazard: GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.
April 20, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Aisys CS2 anesthesia..
Hazard: GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.
April 13, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to sup
Hazard: Ferrous material in the SIGNA Pioneer Table Control Box (TCB) could cause unexpected attraction to the MR system's high strength magnetic field during servicing activities. This could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the TCB from the magnetic field. There have been no events reported as a result of this issue. Clinical scanni
March 16, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated f
Hazard: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
March 16, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for
Hazard: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.