Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Volcano CORE M2 Vascular System Recalled by Volcano Corporation Due to The incorrect resistor has been used in affected...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Volcano Corporation directly.
Affected Products
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
Quantity: 8 devices
Why Was This Recalled?
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Where Was This Sold?
Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
About Volcano Corporation
Volcano Corporation has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report