Volcano Corporation
14 recalls on record · Latest: Apr 13, 2022
FDA Devices Moderate Apr 13, 2022
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
FDA Devices Moderate Dec 18, 2019
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1)…
FDA Devices Moderate May 23, 2018
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology …
FDA Devices Moderate Dec 6, 2017
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R…
FDA Devices Moderate Jun 1, 2016
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobi…
FDA Devices Moderate Mar 9, 2016
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be…
FDA Devices Moderate Mar 9, 2016
Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean …
FDA Devices Moderate Sep 9, 2015
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus In…
FDA Devices Moderate Jul 29, 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; …
FDA Devices Moderate Jul 29, 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; …
FDA Devices Moderate Jul 29, 2015
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 ki…
FDA Devices Moderate Jul 1, 2015
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels i…
FDA Devices Moderate Sep 24, 2014
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and prec…
FDA Devices Moderate Sep 19, 2012