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U.S. Department of Health and Human Services

Class 2 Device Recall Infraredx

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  Class 2 Device Recall Infraredx see related information
Date Initiated by Firm December 15, 2016
Create Date January 03, 2017
Recall Status1 Terminated 3 on October 09, 2018
Recall Number Z-0940-2017
Recall Event ID 76014
510(K)Number K141682  
Product Classification Catheter, intravascular, plaque morphology evaluation - Product Code OGZ
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
Code Information Serial Numbers: MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)
Recalling Firm/
Manufacturer		 Infraredx, Inc.
34 3rd Ave
Burlington MA 01803-4414
For Additional Information Contact SAME
781-221-0053
Manufacturer 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 2		 Device Design
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.
Quantity in Commerce 7 units
Distribution Worldwide Distribution - US including MI and Internationally to South Korea
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OGZ and Original Applicant = Infraredx, Inc.
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