Recall Z-0940-2017
Infraredx, Inc. · initiated December 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Serial Numbers: MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)
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
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0940-2017
- Initiated
- December 15, 2016
- Terminated
- October 9, 2018
- Product code
- OGZ – Catheter, Intravascular, Plaque Morphology Evaluation
- Quantity
- 7 units
- Distribution
- Worldwide Distribution - US including MI and Internationally to South Korea
- Recalling firm
- Infraredx, Inc., Burlington, MA