CLASS II Device recall · Reported 11 Jan 2017 · FDA Enforcement Report

TVC Imaging System recalled by Infraredx

Infraredx is recalling TVC Imaging System, distributed nationwide in the US. The recall was initiated on 15 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)

Quantity recalled7 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0940-2017
FDA event ID: 76014
Recalling firm: Infraredx, Burlington, MA
Classification: Class II
Status: Terminated
Recall initiated: 15 Dec 2016
FDA classified: 3 Jan 2017
Reported: 11 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

15 Dec 2016	Recall initiated by company
3 Jan 2017	Classified by FDA	+19 days
11 Jan 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - US including MI and Internationally to South Korea

Nationwide Michigan

Questions about this recall

Is TVC Imaging System recalled?

Yes. Infraredx recalled TVC Imaging System on 15 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-0940-2017.

Why was it recalled?

Which lots are affected?

Serial Numbers: MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)

Where was it sold?

Worldwide Distribution - US including MI and Internationally to South Korea

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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