The Recall Desk

Manufacturer

GE OEC Medical Systems, Inc

48 recalls in our database name GE OEC Medical Systems, Inc as the manufacturing or recalling firm.

What the numbers show

Total
48
Critical
0
Severe
2
Most recent
2024-12-25

Of the 48 recalls from GE OEC Medical Systems, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–48 of 48

  • ModerateFDA (Devices)·Z-0195-2015·2014-11-19

    GE OEC 9800 Medical Imaging Systems Field Correction for Component Revision

    GE Healthcare is correcting 311 OEC 9800 imaging systems worldwide because prior component revisions may have been incorrectly installed.

    Product
    Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0192-2015·2014-11-19

    GE OEC UroView 2800 Imaging Systems Field Correction for Component Revision

    GE Healthcare is correcting OEC UroView 2800 systems because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1462-2014·2014-04-23

    GE OEC 9900 Elite Mobile Fluoroscopy System Recall for Monitor Fall Risk

    GE Healthcare is recalling 453 OEC 9900 Elite mobile fluoroscopy systems because defective screws may cause the workstation monitor to fall forward.

    Product
    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. Examples of clinical application may include cholangiography, e
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0524-2014·2013-12-25

    GE Recalls InstaTrak and ENTrak Computer-Assisted Navigation Systems

    GE OEC Medical Systems is recalling InstaTrak and ENTrak navigation systems due to potential safety issues.

    Product
    InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2251-2012·2012-09-05

    GE OEC Surgical Navigation Systems Recalled for Unvalidated Headset Configuration

    GE OEC Medical Systems is recalling 768 surgical navigation systems because the Inverted Headset Placement is not a validated configuration.

    Product
    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 anatomical structures during open or percutaneous surgical p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2012·2012-08-29

    GE OEC InstaTrak 3500 Carts Recalled for Tipping Hazard

    GE Healthcare is recalling 99 OEC InstaTrak 3500 Carts because the imaging arm may cause the cart to tip over during use.

    Product
    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 benefit from the use of stereotactic surgical technique. The s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2012·2012-08-29

    GE OEC Recalls 9800 Fluoroscopic X-Ray Systems Due to Hard Drive Defects

    GE OEC is recalling 9800 fluoroscopic x-ray systems because a replacement hard drive can cause system shutdowns, data loss, or data corruption.

    Product
    892.1650 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 interv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2012·2012-08-29

    GE OEC Injection Cable Recall for Potential Erroneous Contrast Injection

    GE OEC Medical Systems is recalling OEC Injection Cables due to a potential for erroneous auto-injection of contrast dye.

    Product
    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 00-883654-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2241-2012·2012-08-29

    GE OEC Fluoroscopes Recalled for Snubber Board Safety Standard Non-Compliance

    GE OEC Medical Systems is recalling 845 fluoroscopes because the Snubber Board does not meet IEC 60601-1 safety standards for voltage isolation.

    Product
    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 High Voltage Transformer. System model number A349855, Snubb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2221-2012·2012-08-29

    GE Healthcare Recalls OEC 8800 Mobile X-ray Systems for Linearity Defect

    GE Healthcare is recalling 175 OEC 8800 Mobile Fluoroscopic X-ray Systems worldwide because they did not meet manufacturer specifications for linearity.

    Product
    GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2136-2012·2012-08-15

    GE OEC Medical Systems Recalls FluoroTrak Spinal Navigation Application

    GE OEC Medical Systems is recalling 17 FluoroTrak Spinal Navigation Applications because they may display incorrect instrument positions relative to reference images.

    Product
    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 stereotactic surgical technique. The system provides a refe
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2125-2012·2012-08-08

    GE OEC Medical Systems Recalls OEC 9800 Plus Digital Imaging Systems

    GE OEC Medical Systems is recalling OEC 9800 Plus Digital imaging systems due to a hard disk drive issue. The recall covers 82 units distributed worldwide.

    Product
    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 include cholangiography, endoscopic, urologic, orthopedic,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2012·2012-08-08

    GE OEC Medical Systems Recalls Mobile C-Arm Devices for Hard Disk Drive Issue

    GE OEC Medical Systems is recalling OEC MiniView 6800 Mobile C-Arms due to a hard disk drive issue. The recall covers 82 units distributed worldwide.

    Product
    OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2127-2012·2012-08-08

    GE OEC Medical Systems Recalls UroView 2800 Imaging Devices

    GE OEC Medical Systems is recalling UroView 2800 and other imaging devices due to hard disk drive issues. The recall covers 82 units distributed worldwide.

    Product
    UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2038-2012·2012-08-01

    GE OEC 9800 C-arm Systems Recalled for Power Supply Defect

    GE OEC Medical Systems is recalling 8,214 OEC 9800 C-arm systems worldwide because the vertical lift column power supply is defective and subject to early life failure.

    Product
    OEC 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 pro
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2065-2012·2012-08-01

    GE OEC 8800 Flexview X-ray System Recalled for Safety Issues

    GE OEC Medical Systems is recalling OEC 8800 Flexview x-ray systems due to intermittent safety issues including navigation tracking inaccuracy and system lock-up.

    Product
    OEC 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 c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2012·2012-08-01

    GE OEC 6800 Miniview X-ray System Recalled for Safety Issues

    GE OEC Medical Systems is recalling 1,933 OEC 6800 Miniview fluoroscopic x-ray systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.

    Product
    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 including but not limited to surgical orthopedic and extremit
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2026-2012·2012-07-25

    GE OEC Motorized C-Arm Systems Recalled for Defective Power Supply

    GE OEC Medical Systems is recalling OEC 9800 series motorized C-arm systems because a defective vertical lift column power supply is subject to early life failure.

    Product
    OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and spot-film
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2025-2012·2012-07-25

    GE OEC 9900 Elite C-arm System Recalled for Power Supply Defect

    GE OEC recalled 726 OEC 9900 Elite C-arm systems worldwide due to a defective vertical lift column power supply identified during an FDA inspection.

    Product
    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 structures during open or percutaneous surgical procedures. It
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2027-2012·2012-07-25

    GE OEC 8800 Flexiview Imaging Device Recall for Defective Power Supply

    GE OEC Medical Systems is recalling OEC 8800 Flexiview imaging devices because an FDA inspection found a defective vertical lift column power supply subject to early life failure.

    Product
    OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventio
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1989-2012·2012-07-18

    GE Axcess Cranial Screw Recalled Due to Breakage During Insertion

    GE Healthcare is recalling 15 kits of Axcess Cranial Screws because they may break during insertion, posing a potential health hazard.

    Product
    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 is intended to be used when rigid fixation of a tracking
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1985-2012·2012-07-18

    GE OEC InstaTrak 3500 Plus Surgical Navigation System Software Recall

    GE OEC Medical Systems recalled 86 InstaTrak 3500 Plus surgical navigation systems due to software-related issues. The recall was initiated in 2006 but recently classified by the FDA due to administrative delays.

    Product
    InstaTrak 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 co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1865-2012·2012-07-04

    GE OEC Uroview 2800 Recalled for Intermittent Safety Issues

    GE OEC Medical Systems is recalling 717 OEC Uroview 2800 fluoroscopic imaging systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.

    Product
    OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states