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
FDA Recall Z-0940-2017 · Posted None
Recalling FirmInfraredx, Inc.
Recall StatusTerminated
Product CodeOGZ
Date Initiated2016-12-15
Date Terminated2018-10-09
Product Quantity7 units
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
Firm Action
Infraredx, Inc. sent an Urgent Product Recall Medical Device Field Correction letter dated December 15, 2016, describing the problem and replacing the defective lasers. A Field Service Representative will contact customers to schedule a replacement of the system's laser rack module. If customers receive this letter and are not contacted within 48 hours, please call Infraredx Technical Support@ 1-800-596-3104.
For questions regarding this recall call 781-221-0053.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US including MI and Internationally to South Korea
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.