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GE OEC Medical Systems Recalls
48 recalls on record · July 4, 2012 to December 25, 2024 · 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 25, 2024Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoros
Hazard: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
December 25, 2024Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is de
Hazard: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
December 25, 2024Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide
Hazard: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
December 25, 2024Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging sy
Hazard: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
August 9, 2023Medical DevicesFDA
GE OEC Medical Systems, Inc recalls Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N
Hazard: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
August 9, 2023Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC Elite Systems with 9-inch Image Intensifier
Hazard: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
August 9, 2023Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9900 Systems with 9-inch Image Intensifier
Hazard: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
August 9, 2023Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9800 Systems with 9-inch Image Intensifier
Hazard: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
August 9, 2023Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Hazard: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
August 4, 2021Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy,
Hazard: There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
August 4, 2021Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic an
Hazard: There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
March 22, 2017Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
Hazard: OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
February 1, 2017Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9900 Elite. MDL Numbers: D148942, D155043
Hazard: GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
February 1, 2017Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9800. MDL Numbers: D222250, D141598
Hazard: GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
January 18, 2017Medical DevicesFDA
GE OEC Medical Systems, Inc recalls The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient dur
Hazard: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
January 18, 2017Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician
Hazard: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
January 18, 2017Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the p
Hazard: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
October 19, 2016Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray
Hazard: GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.
August 31, 2016Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9800, fluoroscopic x-ray system
Hazard: A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
August 31, 2016Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC UroView 2800, fluoroscopic x-ray system
Hazard: A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
June 17, 2015Medical DevicesFDA
GE OEC Medical Systems, Inc recalls GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Hazard: Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
January 21, 2015Medical DevicesFDA
GE OEC Medical Systems, Inc recalls GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedure
Hazard: mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
January 21, 2015Medical DevicesFDA
GE OEC Medical Systems, Inc recalls GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedur
Hazard: mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
November 19, 2014Medical DevicesFDA
GE OEC Medical Systems, Inc recalls Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during
Hazard: GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
November 19, 2014Medical DevicesFDA
GE OEC Medical Systems, Inc recalls FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide
Hazard: GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
November 19, 2014Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic
Hazard: GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
November 19, 2014Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during d
Hazard: GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
April 23, 2014Medical DevicesFDA
GE OEC Medical Systems, Inc recalls The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic
Hazard: GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.
December 25, 2013Medical DevicesFDA
GE OEC Medical Systems, Inc recalls InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Hazard: GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.
September 5, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; a
Hazard: GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.