BEUDAMED
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    Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.

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

    Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.

    FDA Enforcement
    Class II ·Terminated·Volcano Corporation·March 9, 2016

    Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.

    FDA Enforcement
    Class II ·Terminated·Volcano Corporation·March 9, 2016

    Volcano pcFM Software Kit ; Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624. The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data.

    FDA Recall
    Terminated ·Volcano Corporation·Product code IYO·June 11, 2010

    Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.

    FDA Recall
    Terminated ·Volcano Corporation·Product code IYO·August 24, 2012

    Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.

    FDA Recall
    Terminated ·Volcano Corporation·Product code IYO·June 29, 2010

    FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary and peripheral arteries to measure blood flow velocities during diagnostics angiography and/or interventional procedures.

    FDA Recall
    Terminated ·Volcano Corporation·Product code DQX·October 6, 2009

    Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.

    FDA Recall
    Terminated ·Volcano Corporation·Product code KKX·February 5, 2016

    Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.

    FDA Recall
    Terminated ·Volcano Corporation·Product code KKX·February 5, 2016

    Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.

    FDA Recall
    Terminated ·Volcano Corporation·Product code PDU·July 22, 2015

    Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001 size 4.2F, and part number 1451-003 size 5.8F, distributed by Volcano Corporation.

    FDA Recall
    Terminated ·Volcano Corporation·Product code OGX·November 3, 2010

    Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

    FDA Recall
    Terminated ·Volcano Corporation·Product code IYO·June 22, 2015

    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

    FDA Recall
    Terminated ·Volcano Corporation·Product code IYO·June 22, 2015

    Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

    FDA Recall
    Terminated ·Volcano Corporation·Product code OBJ·April 25, 2016

    Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

    FDA Recall
    Terminated ·Volcano Corporation·Product code OBJ·June 4, 2015

    Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

    FDA Recall
    Terminated ·Volcano Corporation·Product code OBJ·March 29, 2017

    Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.

    FDA Recall
    Terminated ·Volcano Corporation·Product code OBJ·October 17, 2018

    Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.

    FDA Recall
    Terminated ·Volcano Corporation·Product code OBJ·October 17, 2018

    Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

    FDA Recall
    Terminated ·Volcano Corporation·Product code OBJ·March 29, 2017

    Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.

    FDA Recall
    Terminated ·Volcano Corporation·Product code IYO·November 7, 2018