Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Volcano Imaging System s5i REF 807400001 Recalled by Volcano Corporation Due to On certain Impacted Systems, an unexpected Microsoft Windows...
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
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished REF 400-0100.08-R; CORE Imaging System REF 400-0100.02 For intravascular ultrasound imaging.
Quantity: 1166 Units
Why Was This Recalled?
On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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