Recall Register

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GE OEC Medical Systems, Inc

FDA recalling firm · 28 enforcement events · 48 product records · 2006–2024 · UT

GE OEC Medical Systems, Inc has 28 FDA enforcement events on this register (48 product records) between 2006 and 2024: 28 device; the busiest year was 2006 with 6.

21% of its events are Class I; the most common class is Class II (22). 2 events are listed as ongoing; the recalling firm's address is in UT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
21 Nov 2024OEC 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 fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical…DeviceClass II4Ongoing
15 May 2023OEC Flexiview 8800 Systems with 9-inch Image IntensifierDeviceClass II5Ongoing
10 Jun 2021OEC 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 surgical proceduresDeviceClass II2Terminated
21 Feb 2017OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical SystemsDeviceClass II1Terminated
27 Dec 2016OEC 9800. MDL Numbers: D222250, D141598DeviceClass II2Terminated
19 Dec 2016OEC 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 cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and…DeviceClass II3Terminated
23 Sep 2016OEC 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 and pediatric populations for orientations between patient anatomy and surgical instruments. The…DeviceClass II1Terminated
22 Jul 2016OEC UroView 2800, fluoroscopic x-ray systemDeviceClass II2Terminated
3 Oct 2014OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional proceduresDeviceClass II4Terminated
15 Sep 2014GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.DeviceClass II2Terminated
22 May 2014GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)DeviceClass II1Terminated
31 Mar 2014The 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. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic,…DeviceClass II1Terminated
26 Nov 2013InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),DeviceClass II1Terminated
26 Apr 2010GE 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 High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5.…DeviceClass II1Terminated
6 Nov 2009892.1650 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 specifically designed for use in diagnostic and interventional cardiac imaging procedures,…DeviceClass II1Terminated
22 Jun 2009OEC 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 anatomical structures during open or percutaneous surgical procedures. It is intended for use in…DeviceClass I1Terminated
10 Oct 2008GEHC 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 00-883654-01.DeviceClass II1Terminated
22 Feb 2008OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features…DeviceClass I1Terminated
19 Nov 2007OEC 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 structures during open or percutaneous surgical procedures. It is indicated for use in medical…DeviceClass II3Terminated
19 Oct 2007GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.DeviceClass II1Terminated
2 Apr 2007Radiological 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 stereotactic surgical technique. The system provides a reference to rigid anatomical structures such…DeviceClass I1Terminated
27 Mar 2007OEC 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 include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical…DeviceClass II3Terminated
20 Nov 2006OEC 8800 Flexview, 892.1650 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 procedures. Clinical applications may include cholangiography, urologic, endoscopic,…DeviceClass I1Terminated
20 Nov 2006OEC 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 including but not limited to surgical orthopedic and extremity imagine. The device is not intended for…DeviceClass I1Terminated
20 Nov 2006OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.DeviceClass II1Terminated
8 Nov 2006The 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 is intended to be used when rigid fixation of a tracking device to bone is required.DeviceClass II1Terminated
11 Oct 2006OEC 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 benefit from the use of stereotactic surgical technique. The system provides a reference to rigid…DeviceClass II1Terminated
15 Sep 2006InstaTrak with Multiple Dataset Navigation, 892.2050 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 procedures. It is indicated for use in medical conditions that may benefit from the use of…DeviceClass I1Terminated

By type and class

Device28
Class II22
Class I6

Class I: 21% of this firm's events; 18% of all events on the register.

Events by year

06
08
10
12
14
16
18
20
22
24
26
Enforcement events for GE OEC Medical Systems, Inc by year initiated.

Questions and answers

How many FDA recalls has GE OEC Medical Systems, Inc had?

28 enforcement events (48 product records) on this register, 2006–2024: 28 device.

Are any GE OEC Medical Systems, Inc recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are GE OEC Medical Systems, Inc recalls?

22 Class II, 6 Class I. 21% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.