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U.S. Department of Health and Human Services

Class 2 Device Recall Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System

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  Class 2 Device Recall Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System see related information
Date Initiated by Firm September 23, 2013
Date Posted July 08, 2015
Recall Status1 Terminated 3 on July 09, 2015
Recall Number Z-2044-2015
Recall Event ID 71404
510(K)Number K123898  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging
and Pressure System;
Product/Part numbers: s5i -806300-020 ;
s5ix/s5iz - 807400-001;
CORE - 400-0 I 00.02.

Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
Code Information Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02.   All software versions
Recalling Firm/
Manufacturer		 Volcano Corp
3721 Valley Centre Dr Ste 500
San Diego CA 92130-3328
For Additional Information Contact Joe Burnett, IGT
858-764-1421
Manufacturer Reason
for Recall		 A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Volcano and Philips sent an Advisory Notice letter dated September 23, 2013 to all impacted customers. The letter identified the affected product, problem and actions to be taken. For question contact your Volcano and Philips representative.
Quantity in Commerce 227 total units - all models
Distribution Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.
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
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