FDADecember 15, 2016device
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 (...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
infraredx
Recall history
No related federal recalls on record for this brand yet.
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