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.
August 7, 2019Medical DevicesFDA
GE Healthcare, LLC recalls GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for s
Hazard: Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
July 31, 2019Medical DevicesFDA
GE Healthcare, LLC recalls MAC VU360, Model Number 2030360-001, Electrocardiograph
Hazard: Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.
July 24, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Hazard: Potential for a transducer mis-alignment in certain transvaginal probes.
July 24, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
Hazard: Potential for a transducer mis-alignment in certain transvaginal probes.
July 24, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Comput
Hazard: Additional low dose radiation exposure.
July 17, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are u
Hazard: The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.
July 17, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are
Hazard: The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.
July 10, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review,
Hazard: There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
July 10, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and f
Hazard: There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
July 3, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW
Hazard: There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
July 3, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal V
Hazard: There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
July 3, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL
Hazard: ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
July 3, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 2
Hazard: ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
July 3, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber,
Hazard: ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
July 3, 2019Medical DevicesFDA
GE Healthcare, LLC recalls ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/
Hazard: ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
July 3, 2019Medical DevicesFDA
GE Healthcare, LLC recalls ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-00
Hazard: ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
June 26, 2019Medical DevicesFDA
GE Healthcare, LLC recalls LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H4
Hazard: Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
June 26, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emiss
Hazard: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
June 26, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emissio
Hazard: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
June 26, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission
Hazard: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
June 26, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Posit
Hazard: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
June 26, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron
Hazard: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
June 26, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron
Hazard: GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
June 19, 2019Medical DevicesFDA
GE Healthcare, LLC recalls GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2
Hazard: There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.
June 19, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performa
Hazard: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
June 19, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system f
Hazard: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
June 19, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed f
Hazard: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
June 19, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your s
Hazard: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
June 19, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote con
Hazard: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
May 8, 2019Medical DevicesFDA
GE Healthcare, LLC recalls Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging proc
Hazard: During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.