| Class 2 Device Recall Intravascular Ultrasound System | |
Date Initiated by Firm | June 22, 2015 |
Date Posted | July 20, 2015 |
Recall Status1 |
Terminated 3 on April 14, 2017 |
Recall Number | Z-2133-2015 |
Recall Event ID |
71654 |
510(K)Number | K123898 |
Product Classification |
System, imaging, pulsed echo, ultrasonic - Product Code IYO
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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 Mobile.
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 Mobile. Part number: 400-0100.01. |
Recalling Firm/ Manufacturer |
Volcano Corporation 2870 Kilgore Rd Rancho Cordova CA 95670-6133
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For Additional Information Contact | Lisa M. Quaglia 978-439-3586 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYO
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