Volcano Corporation recalls Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano…

Recall date

April 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1813-2016

FDA classification

Class II

Brand / firm

Volcano Corporation

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Japan, South Africa, Germany, Sweden, Belgium, France, Italy, Spain, India, Russian Federation, Hungary, Turkey, Poland, Portugal, Costa Rica, Finland, Great Britain, Croatia, India, Chile, Thailand, Mauritius, Iraq, Denmark, Norway, Ireland…

Why it was recalled

Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.