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U.S. Department of Health and Human Services

Class 2 Device Recall Intravascular Ultrasound System

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  Class 2 Device Recall Intravascular Ultrasound System see related information
Date Initiated by Firm June 22, 2015
Date Posted July 20, 2015
Recall Status1 Terminated 3 on April 14, 2017
Recall Number Z-2136-2015
Recall Event ID 71654
510(K)Number K123898  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product 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 CORE

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
Code Information Model CORE. Part number: 400-0100.02.
Recalling Firm/
Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact Lisa M. Quaglia
Manufacturer Reason
for Recall
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
FDA Determined
Cause 2
Software design
Action Urgent Medical Device Correction letters were sent on June 22, 2015 to all affected sites via FED Ex.
Quantity in Commerce A total of 4007 devices, all models
Distribution Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = VOLCANO CORPORATION