Infraredx, Inc. recalls TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasi…

Recall date

December 15, 2016

Source

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

Recall number

Z-0940-2017

FDA classification

Class II

Brand / firm

Infraredx, Inc.

Sold / distributed

Worldwide Distribution - US including MI and Internationally to South Korea

Why it was recalled

Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicating the presence of lipid core plaques) was horizontally-oriented

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

What was recalled

TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views