Reported Jan 11, 2017 · Terminated
TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing…
Infraredx, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Infraredx, Inc. · 34 3rd Ave · Burlington, MA · 01803-4414
Is this the product you have?
- 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
- Lot codes and dates
- Serial NumbersMC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)
- Amount recalled
- 7 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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