BEUDAMED
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    Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.

    FDA Recall
    Terminated ·European Custom Manufacturing B.V. Oost-Om 54 Gemert Netherlands·Product code LDF·April 18, 2011

    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·March 22, 2017

    GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA.

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007

    GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, WI 53223 USA.

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007

    GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.

    FDA Enforcement
    Class II ·Terminated·General Electric Med Systems LLC·June 20, 2012

    SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·January 8, 2014

    The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·September 19, 2012

    Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Innova 2000, manufactured by GE Medical Systems, SCS

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MQB·June 10, 2010

    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·February 21, 2017

    The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation·Product code MED·August 1, 2012

    GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is

    FDA Recall
    Terminated ·GE Medical Systems Information Technologies·Product code HGM·May 21, 2003

    Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 31, 2013

    GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAA·May 1, 2008

    SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation·Product code MLR·November 21, 2013

    Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 31, 2013

    GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAA·May 1, 2008

    GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAA·May 1, 2008

    GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAA·May 1, 2008

    GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DSI·November 8, 2007