Data / Medical devices / United States / Ge Oec Medical Systems, Inc
Ge Oec Medical Systems, Inc: FDA-registered device maker in Salt Lake City, UT, United States, 20 510(k) clearances
Ge Oec Medical Systems, Inc is registered with the FDA (registration 1720753) in Salt Lake City, UT, United States. It lists 4 device types. The FDA files 20 510(k) clearances under its listings, the newest dated March 28, 2024. 59 recall events name it as the recalling firm (6 Class I). Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 1720753
- Address
- 384 N Wright Brothers DR, Salt Lake City, UT, United States, 84116
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- October 16, 1992
- Registered through
- 2027
- Brand names listed
- 9900 Elite Plus, Laser Aimer, Light beam patient position indicator (laser), OEC 3D, OEC 9800, OEC 9800 Plus, OEC 9900 Elite, OEC Elite and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Patient Position, Light-Beam | IWE | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 28, 2024 | K233669 | OEC 3D | OXO | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| March 5, 2021 | K203346 | OEC 3D | OXO | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| November 8, 2019 | K192819 | OEC Elite | OXO | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| November 16, 2017 | K172550 | OEC Elite | OXO | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| August 10, 2017 | K171565 | OEC Elite | OWB | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| July 12, 2017 | K171800 | OEC Elite MiniView | OXO | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| May 19, 2017 | K170752 | OEC Elite | OWB | Substantially Equivalent | Oec Medical Systems, Inc. | accessdata.fda.gov |
| June 21, 2016 | K160131 | OEC Elite MiniView | OXO | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| May 1, 2014 | K132027 | OEC 9800 PLUS | OWB | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| August 16, 2012 | K122234 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| April 6, 2012 | K120613 | OEC 9900 ELITE | OXO | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| October 4, 2011 | K111551 | OEC(R) 9800, OEC(R) 9800 PLUS | OWB | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| May 1, 2009 | K082781 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Healthcare Surgery | accessdata.fda.gov |
| May 2, 2008 | K073543 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| August 15, 2006 | K061953 | 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS | OWB | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| August 18, 2004 | K041932 | OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM | OWB | Substantially Equivalent | Ge Oec Medical Systems, Inc. | accessdata.fda.gov |
| March 20, 2003 | K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM | JAA | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| September 17, 2002 | K022069 | OEC FLUOROTRAK 9800 PLUS | OWB | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| April 17, 2002 | K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM | OWB | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| February 17, 1998 | K974355 | INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) | OWB | Substantially Equivalent | Ge Dec Medical Systems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 21, 2024 | 95846 | Class II | Ongoing | OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluor | 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. | accessdata.fda.gov |
| May 15, 2023 | 92504 | Class II | Ongoing | OEC Flexiview 8800 Systems with 9-inch Image Intensifier | 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. | accessdata.fda.gov |
| June 10, 2021 | 88202 | Class II | Terminated | OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surg | 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. | accessdata.fda.gov |
| May 8, 2020 | 86201 | Class II | Ongoing | The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscop | GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufactur | accessdata.fda.gov |
| February 21, 2017 | 76568 | Class II | Terminated | OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems | OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures. | accessdata.fda.gov |
| December 27, 2016 | 76074 | Class II | Terminated | OEC 9800. MDL Numbers: D222250, D141598 | 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. | accessdata.fda.gov |
| December 19, 2016 | 76033 | Class II | Terminated | OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include ch | 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. | accessdata.fda.gov |
| September 23, 2016 | 75330 | Class II | Terminated | 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 to provide digital spot film imaging and fluoroscopic image guidance for all adult | 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. | accessdata.fda.gov |
| July 22, 2016 | 74808 | Class II | Terminated | OEC UroView 2800, fluoroscopic x-ray system | A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed. | accessdata.fda.gov |
| October 3, 2014 | 69474 | Class II | Terminated | OEC UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures | 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. | accessdata.fda.gov |
| September 15, 2014 | 69660 | Class II | Terminated | GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize. | 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). | accessdata.fda.gov |
| May 22, 2014 | 71298 | Class II | Terminated | GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW) | 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. | accessdata.fda.gov |
| March 31, 2014 | 67867 | Class II | Terminated | The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Example | 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. | accessdata.fda.gov |
| November 26, 2013 | 66992 | Class II | Terminated | InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) | 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. | accessdata.fda.gov |
| February 24, 2011 | 58098 | Not yet classified | Terminated | Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+ | Sensor cables may suffer material degradation when exposed to certain sterilization procedures. | accessdata.fda.gov |
| April 26, 2010 | 62729 | Class II | Terminated | 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 system components from the high voltage system components, such as the X-ray tube or H | 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. | accessdata.fda.gov |
| November 6, 2009 | 62691 | Class II | Terminated | Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features spec | 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. | accessdata.fda.gov |
| August 12, 2009 | 53491 | Not yet classified | Terminated | GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy. | A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate. | accessdata.fda.gov |
| June 22, 2009 | 62715 | Class I | Terminated | OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate a | 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. | accessdata.fda.gov |
| February 19, 2009 | 51856 | Not yet classified | Terminated | GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System | The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration. | accessdata.fda.gov |
| October 10, 2008 | 62746 | Class II | Terminated | GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and | GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye. | accessdata.fda.gov |
| August 29, 2008 | 50083 | Not yet classified | Terminated | GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy. | Under certain conditions, x-ray system may experience operational impairment. | accessdata.fda.gov |
| August 12, 2008 | 49486 | Not yet classified | Terminated | GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy. | Beam limitation may be non-compliant on some X-ray units. | accessdata.fda.gov |
| July 2, 2008 | 49483 | Not yet classified | Terminated | GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah. | Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance E | accessdata.fda.gov |
| April 15, 2008 | 47774 | Not yet classified | Terminated | OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT. | Use of existing four-pedal footswitch on a different machine may cause various operational errors. | accessdata.fda.gov |
| February 22, 2008 | 51222 | Class I | Terminated | OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient du | 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. | accessdata.fda.gov |
| December 20, 2007 | 46212 | Not yet classified | Terminated | Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10. | No Premarket Notification: Product does not have FDA 510(k) approval for use. | accessdata.fda.gov |
| December 14, 2007 | 49536 | Not yet classified | Terminated | GE Healthcare OEC 9900 mobile fluoroscopic x-ray system | Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected. | accessdata.fda.gov |
| November 19, 2007 | 62404 | Class II | Terminated | 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 percutaneous surgical procedures. The system is an aid to locate anatomical struc | 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 | accessdata.fda.gov |
| October 19, 2007 | 62798 | Class II | Terminated | GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy. | X-ray units did not meet manufacturer's specification for linearity. | accessdata.fda.gov |
| October 18, 2007 | 45441 | Not yet classified | Terminated | GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116 | Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field. | accessdata.fda.gov |
| September 28, 2007 | 46349 | Not yet classified | Terminated | GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah. | Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator. | accessdata.fda.gov |
| July 6, 2007 | 38339 | Not yet classified | Terminated | GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. | The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions. | accessdata.fda.gov |
| June 12, 2007 | 38279 | Not yet classified | Terminated | GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. | X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. | accessdata.fda.gov |
| May 24, 2007 | 38272 | Not yet classified | Terminated | OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah. | X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures | accessdata.fda.gov |
| May 18, 2007 | 38373 | Not yet classified | Terminated | Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspi | Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity. | accessdata.fda.gov |
| April 2, 2007 | 62414 | Class I | Terminated | Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of st | 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. | accessdata.fda.gov |
| March 27, 2007 | 62449 | Class II | Terminated | OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may incl | 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 manu | accessdata.fda.gov |
| March 23, 2007 | 37661 | Not yet classified | Terminated | GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862 | Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure. | accessdata.fda.gov |
| March 1, 2007 | 37498 | Not yet classified | Terminated | OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. | During routine service, primary and/or secondary collimators may not have been properly reinstalled. | accessdata.fda.gov |
| February 9, 2007 | 37322 | Not yet classified | Terminated | OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery. | During routine service, a cover may have been installed without the required proper lead shielding. | accessdata.fda.gov |
| January 15, 2007 | 37191 | Not yet classified | Terminated | OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT. | Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall. | accessdata.fda.gov |
| November 20, 2006 | 62387 | Class I | Terminated | OEC 8800 Flexview, Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional pro | 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 | accessdata.fda.gov |
| November 20, 2006 | 62382 | Class I | Terminated | OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient incl | 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 | accessdata.fda.gov |
| November 20, 2006 | 62016 | Class II | Terminated | OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. | 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. | accessdata.fda.gov |
| November 8, 2006 | 62397 | Class II | Terminated | The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin | 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. | accessdata.fda.gov |
| October 11, 2006 | 62744 | Class II | Terminated | OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may bene | 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. | accessdata.fda.gov |
| September 30, 2006 | 36403 | Not yet classified | Terminated | OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc. | X-ray system may lose or mix images and/or lose patient data. | accessdata.fda.gov |
| September 15, 2006 | 62112 | Class I | Terminated | InstaTrak with Multiple Dataset Navigation, System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical proce | 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. | accessdata.fda.gov |
| September 13, 2006 | 36400 | Not yet classified | Terminated | GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc. | Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy. | accessdata.fda.gov |
| August 16, 2006 | 36099 | Not yet classified | Terminated | GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc. | X-ray systems could provide output which exceeds the 20 R/minute limit. | accessdata.fda.gov |
| May 31, 2006 | 35637 | Not yet classified | Terminated | GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems) | Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used. | accessdata.fda.gov |
| March 28, 2006 | 34990 | Not yet classified | Terminated | MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system. | Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure. | accessdata.fda.gov |
| February 6, 2006 | 34730 | Not yet classified | Terminated | GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter | Small retaining pin may detach and fall into the surgical field during stereotactic surgery. | accessdata.fda.gov |
| January 26, 2005 | 31058 | Not yet classified | Terminated | InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body) | Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software. | accessdata.fda.gov |
| December 13, 2004 | 30758 | Not yet classified | Terminated | ENTrak Navigation and Visualization System | Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised. | accessdata.fda.gov |
| September 15, 2004 | 30035 | Not yet classified | Terminated | Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter. | Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove. | accessdata.fda.gov |
| July 12, 2004 | 31057 | Not yet classified | Terminated | ENTrak Navigation and Visualization System | Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit. | accessdata.fda.gov |
| May 12, 2003 | 26383 | Not yet classified | Terminated | Uroview 2000 X-ray System | Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids. | accessdata.fda.gov |
Compare with other makers
- All makers of Interventional Fluoroscopic X-Ray System
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- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of Monitor, Patient Position, Light-Beam
Updated December 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.