BEUDAMED
    79 results · 32ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code OXO·September 20, 2012

    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, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·December 19, 2016

    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OXO·August 30, 2018

    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OXO·August 30, 2018

    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OXO·August 30, 2018

    GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC 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 product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.

    FDA Recall
    Terminated ·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD No. 2 Yong Chang North Rd. Beijing Econ. & Tech. Dev. Zone Beijing China·Product code OXO·September 18, 2013

    Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

    FDA Recall
    Terminated ·Orthoscan, Inc.·Product code OXO·August 31, 2017

    O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OXO·August 30, 2018

    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OXO·August 30, 2018

    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 during diagnostic, interventional, and surgical procedures.

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024

    GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code OXO·September 20, 2012

    GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code OXO·September 20, 2012

    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·September 15, 2014

    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 patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·September 23, 2016

    OEC Flexiview 8800 Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023

    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, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·April 26, 2010

    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OXO·August 30, 2018

    OEC 9900 Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023

    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

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023

    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 procedures.

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024