Ge Oec Medical Systems recalls
Ge Oec Medical Systems appears in 48 official U.S. recall notices indexed by RecallRadar, most recently on 2024-12-25.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 48 |
|---|---|
| Published | 2012-07-04 to 2024-12-25 |
| By agency | FDA Device (48) |
| By classification | Class II (42), Class I (6) |
| By status | terminated (39), ongoing (9) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems
Reason: 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. - OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems
Reason: 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. - OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems
Reason: 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. - OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems
Reason: 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. - OEC Flexiview 8800 Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems
Reason: 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 coul… - OEC 9900 Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems
Reason: 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 coul… - OEC Elite Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems
Reason: 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 coul… - Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems
Reason: 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 coul… - OEC 9800 Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems
Reason: 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 coul… - OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional too…
FDA Device · Class II · 2021-08-04 · Ge Oec Medical Systems
Reason: 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. - OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot imag…
FDA Device · Class II · 2021-08-04 · Ge Oec Medical Systems
Reason: 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. - OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
FDA Device · Class II · 2017-03-22 · Ge Oec Medical Systems
Reason: OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures. - OEC 9800
FDA Device · Class II · 2017-02-01 · Ge Oec Medical Systems
Reason: 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 re… - OEC 9900 Elite
FDA Device · Class II · 2017-02-01 · Ge Oec Medical Systems
Reason: 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 re… - OEC 9800
FDA Device · Class II · 2017-01-18 · Ge Oec Medical Systems
Reason: 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. - The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surg…
FDA Device · Class II · 2017-01-18 · Ge Oec Medical Systems
Reason: 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. - OEC MiniView 6800
FDA Device · Class II · 2017-01-18 · Ge Oec Medical Systems
Reason: 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. - OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed t…
FDA Device · Class II · 2016-10-19 · Ge Oec Medical Systems
Reason: 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, res… - OEC UroView 2800, fluoroscopic x-ray system
FDA Device · Class II · 2016-08-31 · Ge Oec Medical Systems
Reason: A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed. - OEC 9800, fluoroscopic x-ray system
FDA Device · Class II · 2016-08-31 · Ge Oec Medical Systems
Reason: A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed. - GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
FDA Device · Class II · 2015-06-17 · Ge Oec Medical Systems
Reason: 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. - GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize
FDA Device · Class II · 2015-01-21 · Ge Oec Medical Systems
Reason: 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 manuf… - GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize
FDA Device · Class II · 2015-01-21 · Ge Oec Medical Systems
Reason: 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 manuf… - Series OEC 9800
FDA Device · Class II · 2014-11-19 · Ge Oec Medical Systems
Reason: 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. - OEC¿ UroView 2800
FDA Device · Class II · 2014-11-19 · Ge Oec Medical Systems
Reason: 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. - OEC¿ MiniView 6800
FDA Device · Class II · 2014-11-19 · Ge Oec Medical Systems
Reason: 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. - FlexiView 8800 Digital Mobile Imaging System
FDA Device · Class II · 2014-11-19 · Ge Oec Medical Systems
Reason: 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. - The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film image…
FDA Device · Class II · 2014-04-23 · Ge Oec Medical Systems
Reason: 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 for… - InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA)
FDA Device · Class II · 2013-12-25 · Ge Oec Medical Systems
Reason: 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 produc… - OEC IT3000
FDA Device · Class I · 2012-09-05 · Ge Oec Medical Systems
Reason: 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 e… - GEHC OEC Injection Cable for MedRad Provis V Contrast Injector
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems
Reason: GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye. - OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous…
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems
Reason: 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. - GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems
Reason: X-ray units did not meet manufacturer's specification for linearity. - GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal syste…
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems
Reason: 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. - 892.1650 Image-intensified fluoroscopic x-ray system
FDA Device · Class II · 2012-08-29 · Ge Oec Medical Systems
Reason: 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 c… - Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures
FDA Device · Class I · 2012-08-15 · Ge Oec Medical Systems
Reason: 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. - OEC MiniView 6800 Mobile
FDA Device · Class II · 2012-08-08 · Ge Oec Medical Systems
Reason: 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 tha… - OEC 9800 Plus Digital
FDA Device · Class II · 2012-08-08 · Ge Oec Medical Systems
Reason: 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 tha… - UroView 2800
FDA Device · Class II · 2012-08-08 · Ge Oec Medical Systems
Reason: 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 tha… - OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures
FDA Device · Class I · 2012-08-01 · Ge Oec Medical Systems
Reason: 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 s… - OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopi…
FDA Device · Class I · 2012-08-01 · Ge Oec Medical Systems
Reason: 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 s… - OEC 9800
FDA Device · Class I · 2012-08-01 · Ge Oec Medical Systems
Reason: 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… - OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or…
FDA Device · Class II · 2012-07-25 · Ge Oec Medical Systems
Reason: 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… - OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional pro…
FDA Device · Class II · 2012-07-25 · Ge Oec Medical Systems
Reason: 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… - OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imagin…
FDA Device · Class II · 2012-07-25 · Ge Oec Medical Systems
Reason: 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… - The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used…
FDA Device · Class II · 2012-07-18 · Ge Oec Medical Systems
Reason: 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. - InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus
FDA Device · Class I · 2012-07-18 · Ge Oec Medical Systems
Reason: 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… - OEC Uroview 2800, Model number A349855
FDA Device · Class II · 2012-07-04 · Ge Oec Medical Systems
Reason: 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…