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.

1–25 of 48

  • HighFDA (Devices)·Z-0706-2025·2024-12-25

    GE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing

    GE OEC 9800 fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can result in oil leaks and loss of imaging capability. 25 systems distributed in the U.S. and internationally are affected.

    Product
    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series 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, endoscop
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0705-2025·2024-12-25

    OEC 9900 Mobile Fluoroscopic X-Ray System Recall for Sealing Defect

    GE OEC Medical Systems is recalling 78 OEC 9900 Elite mobile fluoroscopy systems due to insufficient sealing of X-ray tubes. The defect can result in oil leaks and loss of fluoroscopic imaging capability.

    Product
    OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application ma
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0703-2025·2024-12-25

    OEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall

    GE OEC Medical Systems is recalling 84 OEC 3D mobile fluoroscopic X-ray systems due to manufacturing defects in X-ray tube sealing that can cause oil leaks and loss of imaging capability.

    Product
    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 fluoroscopic Xray images and volumetric reconstructions durin
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0704-2025·2024-12-25

    Fluoroscopic X-Ray System Recalled for Insufficient X-Ray Tube Sealing

    GE OEC Elite mobile fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can cause oil leaks and loss of imaging capability. Approximately 100 systems have been affected.

    Product
    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2278-2023·2023-08-09

    Medical X-ray Systems Image Intensifier Detachment Injury Risk

    GE OEC Elite Systems with 9-inch Image Intensifier devices may detach during movement if subjected to impact force, potentially causing injury to personnel and bystanders.

    Product
    OEC Elite Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2023·2023-08-09

    Image intensifier detachment hazard in OEC fluoroscopy imaging systems

    GE OEC field upgrade kits for fluoroscopy systems may have image intensifiers that detach during movement, potentially falling and causing injuries.

    Product
    Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2023·2023-08-09

    OEC 9900 Systems Image Intensifier Detachment and Fall Risk

    GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.

    Product
    OEC 9900 Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2275-2023·2023-08-09

    OEC Flexiview 8800 Image Intensifier Risks Detachment During Movement

    GE OEC Medical Systems is recalling two OEC Flexiview 8800 fluoroscopic imaging systems due to image intensifiers that may detach and fall during movement, potentially causing fractures, hematoma, contusion, bruise, or pain.

    Product
    OEC Flexiview 8800 Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2276-2023·2023-08-09

    OEC 9800 Fluoroscopy Systems Image Intensifier May Detach and Fall

    The image intensifier on GE OEC 9800 fluoroscopy systems can detach and fall if the system experiences a large impact force during movement. This could result in injuries including fractures, bruising, and contusion.

    Product
    OEC 9800 Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2021·2021-08-04

    OEC Elite Mobile C-Arm Recalled for Battery Depletion

    GE OEC Medical Systems is recalling 3,570 OEC Elite mobile C-arm imaging systems worldwide due to potential early depletion of the battery that monitors X-ray tube temperature, which could render the system inoperable.

    Product
    OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2021·2021-08-04

    OEC 3D Imaging X-Ray Systems Recalled for Coin Cell Battery Depletion

    GE OEC Medical Systems is recalling certain OEC 3D Imaging fluoroscopic X-ray systems due to potential premature depletion of the coin cell battery used to monitor X-ray tube temperature, which could cause the system to become inoperable.

    Product
    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 surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2017·2017-03-22

    GE OEC FlexiView 8800 Imaging System Recalled for Power Cord Failures

    GE is recalling OEC FlexiView 8800 systems where specific power cords were replaced in 2016 due to intermittent failures causing loss of imaging functionality.

    Product
    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1060-2017·2017-02-01

    GE OEC 9900 Elite Surgical Carts Recalled for Documentation Updates

    GE Healthcare is updating user documentation for OEC 9900 Elite surgical carts to clarify maintenance and component replacement frequencies.

    Product
    OEC 9900 Elite. MDL Numbers: D148942, D155043
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1059-2017·2017-02-01

    GE OEC 9800 Surgical Table Field Action for Documentation Updates

    GE Healthcare is updating user documentation for OEC 9800 surgical tables to clarify maintenance and component replacement schedules.

    Product
    OEC 9800. MDL Numbers: D222250, D141598
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0973-2017·2017-01-18

    GE Healthcare Recalls OEC 9800 Imaging Systems Due to Power Cable Failures

    GE Healthcare is conducting a voluntary field action for OEC 9800 systems because the workstation power cable assembly can cause intermittent power cord failures.

    Product
    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 cholangiography, endoscopy, urologic, orthopedic, neurologic,
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0974-2017·2017-01-18

    GE OEC MiniView 6800 C-Arm Recalled for Power Cable Failures

    GE Healthcare is conducting a voluntary field action for OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 devices due to intermittent power cord failures.

    Product
    OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 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 not intended for wh
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0975-2017·2017-01-18

    GE OEC Mobile Fluoroscopy Systems Recalled for Power Cable Failures

    GE Healthcare is recalling OEC 9900 Elite and other mobile fluoroscopy systems because the workstation power cable assembly can fail intermittently.

    Product
    The OEC 9900 Elite mobile fluoroscopy system 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, neurologic,
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0071-2017·2016-10-19

    GE OEC Brivo Mobile C-Arm X-Ray Recall for Uncontrolled Motion

    GE Healthcare is recalling 148 OEC Brivo mobile C-arm X-ray units because a circuit board failure may cause the C-arm to move vertically without command.

    Product
    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 and pediatric populations for orientations between pati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2628-2016·2016-08-31

    GE OEC UroView 2800 Fluoroscopic X-Ray System Recalled for Monitor Firmware Issue

    GE OEC Medical Systems is recalling 47 OEC UroView 2800 fluoroscopic x-ray systems because a firmware issue may cause the LCD workstation monitor to appear dark with no video displayed.

    Product
    OEC UroView 2800, fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2629-2016·2016-08-31

    GE OEC 9800 Fluoroscopic X-Ray System Recalled for Monitor Firmware Issue

    GE OEC Medical Systems is recalling 47 OEC 9800 fluoroscopic x-ray systems because a firmware issue may cause the LCD workstation monitors to appear dark with no video displayed.

    Product
    OEC 9800, fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1638-2015·2015-06-17

    GE OEC Brivo 865 Plus Mobile X-ray Laser Aimer Assemblies Recalled

    GE OEC Medical Systems is recalling nine mobile X-ray laser aimer assemblies because they were shipped without required laser product certification.

    Product
    GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0840-2015·2015-01-21

    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Recall for Accuracy Deviation

    GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because the accuracy of the x-ray tube potential and current may exceed the manufacturer's specified limits.

    Product
    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0841-2015·2015-01-21

    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Recall for Accuracy Issues

    GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because their accuracy may exceed the design specification of +10%.

    Product
    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0194-2015·2014-11-19

    GE Healthcare Recalls FlexiView 8800 Digital Mobile Imaging Systems

    GE Healthcare is recalling five FlexiView 8800 systems because prior component revisions were potentially installed on these units.

    Product
    FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System 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-0193-2015·2014-11-19

    GE OEC MiniView 6800 C-Arm Recall for Component Revision

    GE Healthcare is recalling 26 OEC MiniView 6800 C-Arms because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ MiniView 6800. 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 not intended for whole-body pediatric imagin
    Category
    Medical Device
    Distribution
    0 states