Infraredx Recalls TVC Imaging System Due to Image Appearance Issues
Infraredx, Inc. is recalling seven TVC Imaging System units because near-infrared images sometimes displayed lipid core plaques with an unusual horizontal orientation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the issue involves an image display anomaly without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Infraredx, Inc. is recalling seven units of the TVC Imaging System model TVC-MC9. This intravascular imaging device is used for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The system simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS).
The recall was initiated because the near-infrared spectroscopic images (Chemograms) generated by the device sometimes demonstrated an unusual appearance. Specifically, the yellow color in the images, which indicates the presence of lipid core plaques, was horizontally oriented in some cases.
The affected units were distributed worldwide, including in the United States (specifically Michigan) and South Korea. The specific serial numbers for the recalled units are MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007, and 12718M00009 (spare laser assembly). Healthcare providers and facilities should contact Infraredx, Inc. for instructions on how to proceed with the recall.
The recalled product
- 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…
- Manufacturer
- Infraredx, Inc.
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Serial Numbers: MC9-15013
- MC9-15006
- MC9-15005
- MC9-15008
- MC9-15012
- MC9-15007 and 12718M00009 (spare laser assembly)
Distribution
Distributed in 1 state:
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