Infraredx, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0940-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 15, 2016

Date Posted: January 11, 2017

Recall Number: Z-0940-2017

Event ID: 76014

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

Status: Terminated

Product Quantity: 7 units

Code Information:

Serial Numbers: MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)

Distribution Pattern:

Worldwide Distribution - US including MI and Internationally to South Korea

Voluntary or Mandated:

Voluntary: Firm initiated