TVC Imaging System recall
TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC…
Why was TVC Imaging System 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)
- Product
- TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC…
- Recalling firm
- Infraredx, Inc.
- Quantity
- 7 units
- Distribution
- Worldwide Distribution - US including MI and Internationally to South Korea
- Recall date
- January 11, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)