TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in pati...
FDA Recall #Z-0940-2017 — Class II — December 15, 2016
Product Description
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
Reason for Recall
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
Recalling Firm
Infraredx, Inc. — Burlington, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7 units
Distribution
Worldwide Distribution - US including MI and Internationally to South Korea
Code Information
Serial Numbers: MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated