TVC Imaging System model TVC-MC9 — Class II medical device recall Z-0940-2017
Terminated recall by Infraredx, Inc., reported 2017-01-11. Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demons
| Recall number | Z-0940-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Infraredx, Inc., Burlington, MA, United States |
| Recall initiated | 2016-12-15 |
| Classified | 2017-01-03 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2018-10-09 |
| Countries outside the US | KR |
| Quantity | 7 units |
| Serial numbers | 12718M00009, MC9-15005, MC9-15006, MC9-15007, MC9-15008, MC9-15012, MC9-15013 |
| Model numbers | TVC-MC9 |
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 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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.