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.
February 22, 2017Medical DevicesFDA
GE Healthcare, LLC recalls Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high sign
Hazard: Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.
January 18, 2017Medical DevicesFDA
GE Healthcare, LLC recalls Infant Warmer System (IWS)
Hazard: GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls SFX
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls RFX
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls Prestilix
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls Prestige VH
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls Prestige SI
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls Prestige II
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls Precision 500D
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls Legacy
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls ADVANTX LCV+
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls ADVANTX LCN+
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls ADVANTX LCLP+
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls ADVANTX LCA
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
January 4, 2017Medical DevicesFDA
GE Healthcare, LLC recalls Innova 2000
Hazard: GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
December 21, 2016Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Avance, Avance CS2, Amingo.
Hazard: GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.
September 14, 2016Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Hazard: GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
July 13, 2016Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Discovery MR750w
Hazard: GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. 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. No injury has been reported to GE as a result of this issue.
June 15, 2016Medical DevicesFDA
GE Healthcare, LLC recalls Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
Hazard: The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
June 15, 2016Medical DevicesFDA
GE Healthcare, LLC recalls MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
Hazard: The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
June 15, 2016Medical DevicesFDA
GE Healthcare, LLC recalls GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applicat
Hazard: GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie
November 18, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic dev
Hazard: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
November 18, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body
Hazard: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
November 18, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for
Hazard: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
November 18, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use a
Hazard: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
November 18, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
Hazard: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
November 18, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use
Hazard: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
November 18, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750
Hazard: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
November 11, 2015Medical DevicesFDA
GE Healthcare recalls The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from va
Hazard: Inaccurate distance measurements with magnified projection X-ray images.
November 11, 2015Medical DevicesFDA
GE Healthcare recalls The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data fr
Hazard: Inaccurate distance measurements with magnified projection X-ray images.