269 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·October 19, 2016
OEC 9800. MDL Numbers: D222250, D141598
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·February 1, 2017
OEC 9900 Elite. MDL Numbers: D148942, D155043
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·February 1, 2017
OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·March 22, 2017
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·June 17, 2015
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.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 4, 2021
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
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 4, 2021
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Hitachi Ltd., Medical System Operations Group·May 9, 2018
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
FDA Recall
Terminated
·BBI SOLUTIONS OEM LTD 8 Tom McDonald Avenue Dundee United Kingdom·Product code GHH·June 1, 2016