PlainRecalls

GE OEC Medical Systems, Inc

30 recalls on record · Latest: Dec 25, 2024

FDA Devices Moderate Dec 25, 2024

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 s…

FDA Devices Moderate Dec 25, 2024

OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spo…

FDA Devices Moderate Dec 25, 2024

OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopi…

FDA Devices Moderate Aug 9, 2023

OEC Flexiview 8800 Systems with 9-inch Image Intensifier

FDA Devices Moderate Aug 9, 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 I…

FDA Devices Moderate Aug 4, 2021

OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adul…

FDA Devices Moderate Feb 1, 2017

OEC 9900 Elite. MDL Numbers: D148942, D155043

FDA Devices Moderate Feb 1, 2017

OEC 9800. MDL Numbers: D222250, D141598

FDA Devices Moderate Jan 18, 2017

OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, sur…

FDA Devices Moderate Jan 18, 2017

OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic vis…

FDA Devices Moderate Aug 31, 2016

OEC UroView 2800, fluoroscopic x-ray system

FDA Devices Moderate Jan 21, 2015

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

FDA Devices Moderate Jan 21, 2015

GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

FDA Devices Moderate Nov 19, 2014

FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, …

FDA Devices Moderate Nov 19, 2014

Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and inte…

FDA Devices Moderate Nov 19, 2014

OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and inte…

FDA Devices Moderate Aug 29, 2012

GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-inje…

FDA Devices Moderate Aug 29, 2012

GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.

FDA Devices Moderate Aug 29, 2012

OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical …

FDA Devices Critical Aug 15, 2012

Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is i…

FDA Devices Moderate Aug 8, 2012

OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general…

FDA Devices Moderate Aug 8, 2012

UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical…

FDA Devices Critical Aug 1, 2012

OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic a…

FDA Devices Critical Aug 1, 2012

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 O…

FDA Devices Moderate Jul 25, 2012

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 p…

FDA Devices Moderate Jul 25, 2012

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 percutaneo…

FDA Devices Moderate Jul 25, 2012

OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. …

FDA Devices Moderate Jul 18, 2012

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 conjunc…

FDA Devices Critical Jul 18, 2012

InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The syst…

FDA Devices Moderate Jul 4, 2012

OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and i…