Z-0940-2017Class II

TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients...

Name: Z-0940-2017 TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients...
Creator: Infraredx, Inc.
Published: 2016-12-15
License: https://open.fda.gov/license/

Nipro Vascular Innovations Americas, Inc. / initiated 2016-12-15 / Terminated / root cause: design

FDA source

Infraredx, Inc. began a recall of TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging... on 2016-12-15. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0940-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-15
Posted: 2017-01-03
Terminated: 2018-10-09
Recalling firm: Nipro Vascular Innovations Americas, Inc.
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
Product code: OGZ Catheter, Intravascular, Plaque Morphology Evaluation
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
Root cause tag: design
FDA root cause: Device Design
Action: Infraredx, Inc. sent an Urgent Product Recall Medical Device Field Correction letter dated December 15, 2016, describing the problem and replacing the defective lasers. A Field Service Representative will contact customers to schedule a replacement of the system's laser rack module. If customers receive this letter and are not contacted within 48 hours, please call Infraredx Technical Support@ 1-800-596-3104. For questions regarding this recall call 781-221-0053.
Quantity in commerce: 7 units
Distribution: Worldwide Distribution - US including MI and Internationally to South Korea
Product codes and lots: Serial Numbers: MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0940-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0940-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-03

Product code OGZ

K141682Class IITvc Imaging System, Tvc Insight CatheterInfraredx, Inc. / cleared 2014-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)