Recall Z-1813-2016— Volcano Corporation

Name: FDA recall Z-1813-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-25

Class II · Terminated

Class II FDA medical device recall by Volcano Corporation, initiated 2016-04-25, terminated 2018-01-02. It names 2 FDA 510(k) clearances: K123898, K071554. Product: 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.. Reason: Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot.

Recalling firm: Volcano Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-04-25
Terminated: 2018-01-02
Firm location: Rancho Cordova, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K123898 — VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEMVolcano Corporation·cleared 2013-01-14
K071554 — VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEMVolcano Corporation·cleared 2008-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot

Data sourced from openFDA. This site is unofficial and independent of the FDA.