Recall Z-0940-2017— Infraredx, Inc.

Name: FDA recall Z-0940-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-15

Class II · Terminated

Class II FDA medical device recall by Infraredx, Inc., initiated 2016-12-15, terminated 2018-10-09. It names one FDA 510(k) clearance: K141682. Product: 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: 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.
Classification: Class II
Status: Terminated
Initiated: 2016-12-15
Terminated: 2018-10-09
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K141682 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETERInfraredx, Inc.·cleared 2014-11-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.