Volcano Corporation recalls Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technolog

Recalled July 29, 2015 · FDA recall Z-2136-2015 · Volcano

Hazard

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. · FDA Class II

Units

A total of 4007 devices, all models

Sold at

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

Description

A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

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

Manufacturer(s)

Volcano Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →