BEUDAMED
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    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OWG·April 8, 2020

    OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable l6-output, multi-channel stimulator (lPO - Implantable Pulse Generator) with a rechargeable battery power source. The lPG, commonly implanted in the abdomen or buttock area, can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals.

    FDA Recall
    Terminated ·Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342·Product code LGW·April 22, 2008

    Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray system

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Omega IV and Omega V tables on GE Advantx-E imaging system, used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MQB·December 22, 2009

    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·August 21, 2013

    GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor

    FDA Recall
    Terminated ·Ge Healthcare, Llc·Product code BSZ·March 12, 2010

    GE, 1009-9002-000 Avance Anesthesia Machine and Monitor

    FDA Recall
    Terminated ·Ge Healthcare, Llc·Product code BSZ·March 12, 2010

    GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·September 25, 2009

    GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 24, 2013

    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 Enforcement
    Class II ·Terminated·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD·October 30, 2013

    GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code OWB·October 21, 2011

    AMX Navigate Mobile X-Ray System

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code IZL·June 24, 2021

    GE Signa Advantage nuclear magnetic resonance imaging system.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·August 19, 2005

    GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·February 11, 2010

    GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·February 11, 2010

    PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.

    FDA Enforcement
    Class II ·Terminated·Remel Inc·August 19, 2015