Volcano Corp recalls Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020…

Recall date

September 23, 2013

Source

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

Recall number

Z-2044-2015

FDA classification

Class II

Brand / firm

Volcano Corp

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.

Why it was recalled

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.

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 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.