BEUDAMED
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    Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153; Siemens Medical Solutions USA, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007

    Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code KPQ·January 3, 2008

    AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code KPQ·May 24, 2012

    Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT, Part No: 54 96 984; Siemens Medical Solutions USA, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007

    Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016; Siemens Medical Solutions USA, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007

    Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems

    FDA Recall
    Terminated ·Varian Medical Systems Inc·Product code KPQ·June 25, 2007

    SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·December 11, 2013

    Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems; Part Number: 5488460; Product is manufactured and distributed by Siemens Medical Solutions, Oncology Care System, 4040 Nelson Ave, Concord CA The product is indicated for use in Radiation therapy simulation.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·March 10, 2008

    Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·October 10, 2014

    Si emans Evansi, with patient table, Part No: 44 81 586, and without patient table Part No: 44-81-669; Siemens Medical Solutions USA, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007

    AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code KPQ·February 2, 2009

    Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. Radiation therapy simulation system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·November 6, 2008

    Si emans Simiae NT Cassette Holder Electronic Imaging Device (Image Identifier) Part No. 54 96 992 ;Siemens Medical Solutions USA, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007

    RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced susceptibility to most of the carbapenem agents.

    FDA Recall
    Terminated ·Gibson Laboratories Inc·Product code JSO·December 17, 2009

    AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·October 11, 2017

    ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·September 30, 2015

    LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length LSM0800626 6mm 26 mm 80 cm LSM1350626 6 mm 26 mm 135 cm LSM0800637 6 mm 37 mm 80 cm LSM1350637 6 mm 37 mm 135 cm LSM0800726 7 mm 26 mm 80 cm LSM1350726 7 mm 26 mm 135 cm Product Usage: The LIFESTREAM Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesions lengths up to 100mm.

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·December 25, 2019

    Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code KEY·October 30, 2007

    Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code KEY·September 6, 2007

    LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

    FDA Recall
    Terminated ·Physio-Control, Inc.·Product code MKJ·January 27, 2016