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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.
August 29, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provi
Hazard: GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
August 29, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protectio
Hazard: GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation.
August 29, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imagi
Hazard: GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing unanticipated system shut downs, no boots, data loss or data mix, or unexpected hard drive corruption.
August 29, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures durin
Hazard: GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.
August 29, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic exami
Hazard: X-ray units did not meet manufacturer's specification for linearity.
August 15, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous
Hazard: The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.
August 8, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patien
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and
August 8, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provi
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and
August 8, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and
August 1, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is desig
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod
August 1, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional proce
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo
August 1, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoro
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure.
July 25, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
July 25, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic a
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
July 25, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structu
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
July 18, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is
Hazard: GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insertion. There is a possibility that breaking of the screws could lead to a health hazard.
July 18, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Pro
Hazard: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues.
July 4, 2012Medical DevicesFDA
GE OEC Medical Systems, Inc recalls OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient durin
Hazard: Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot.