Lower risk Medical device recall · FDA · Published March 22, 2018

Philips Volcano CORE M2 Vascular System Recall: Incorrect Resistor Causes Bright IVUS

Philips Volcano CORE M2 Vascular System (Part #400-0100.17) with specific serial numbers recalled due to incorrect resistor causing overly bright IVUS images. Affected units may show inaccurate vascular imaging results.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1891-2018Medical device Volcano ›

Lower-risk recall

The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.

Take action

Contact the company

Recalling firmVolcano Corporation2870 Kilgore Rd · Rancho Cordova, CA 95670-6133

✎ GovInfoNow plain-language explainer

Philips Volcano CORE M2 Vascular System units with specific serial numbers were recalled because an incorrect resistor causes overly bright IVUS images. This could lead to inaccurate vascular imaging results for medical use. Read more at govinfonow.com/recall/71659-philips-volcano-core-m2-vascular-system-recall-incorrect-resistor-causes.

Source Summary by GovInfoNow · govinfonow.com/recall/71659-philips-volcano-core-m2-vascular-system-recall-incorrect-resistor-causes · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1891-2018

Cite this page

“Philips Volcano CORE M2 Vascular System Recall: Incorrect Resistor Causes Bright IVUS.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71659-philips-volcano-core-m2-vascular-system-recall-incorrect-resistor-causes. Based on FDA recall #Z-1891-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1891-2018%22&limit=1).

The FDA announced on March 22, 2018, that Volcano Corporation is recalling Philips Volcano CORE M2 Vascular Systems due to an incorrect resistor causing overly bright IVUS images. The agency classified the recall as Class II.

How to tell if you have it

Brand: Volcano
Product: Philips Volcano CORE M2 Vascular System
Part #: 400-0100.17
Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077
Quantity: 8 devices

The hazard

The incorrect resistor in the affected CORE M2 Imaging Systems causes noise and results in an overly bright IVUS Image, according to the FDA.

Context

GovInfoNow's records show Volcano Corporation has four other recalls on record since November 3, 2017. Other recent recalls of similar products include Philips Incisive CT Recall (December 3, 2025) and PIE Medical Imaging 3mensio Workstation Software Recall (May 7, 2026).

How to tell if you have this one

Check for the serial numbers: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077. The product is a Philips Volcano CORE M2 Vascular System used for vascular imaging in medical settings.

Brand
Volcano
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify if your unit has one of the listed serial numbers: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, or 126620093077.

Where it went and when

Where it was distributed

Distributed in 6 states, and outside the U.S.

FDA distribution: “Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Connecticut, Maryland, North Carolina, Oregon, Tennessee.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

Mar 22, 2018Firm started the recall
May 17, 2018FDA classified it Class II
May 23, 2018Published in FDA’s Enforcement Report
Apr 28, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Volcano recalls

Link to this recall

<a href="https://govinfonow.com/recall/71659-philips-volcano-core-m2-vascular-system-recall-incorrect-resistor-causes">Philips Volcano CORE M2 Vascular System Recall: Incorrect Resistor Causes Bright IVUS (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1891-2018 (March 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1891-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.