Z-0940-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2017
- Initiation Date
- December 15, 2016
- Termination Date
- October 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
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
Distribution Pattern
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)