Recall Z-2135-2015— Volcano Corporation
Class II · Terminated
Class II FDA medical device recall by Volcano Corporation, initiated 2015-06-22, terminated 2017-04-14. It names one FDA 510(k) clearance: K123898. 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 s5ix/s5iz 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. Reason: A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances..
- Recalling firm
- Volcano Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-22
- Terminated
- 2017-04-14
- Firm location
- Rancho Cordova, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz 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
Reason for recall
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Data sourced from openFDA. This site is unofficial and independent of the FDA.