Volcano Imaging Systems Recalled Due to Unexpected Windows Security Dialog
Volcano Corporation is recalling specific intravascular ultrasound imaging systems because an unexpected Microsoft Windows Security dialog may appear during use, potentially affecting device operation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software defect may adversely affect operation during use, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Volcano Corporation is recalling 1,166 units of Volcano Imaging System s5i and CORE Mobile Imaging Systems. The recall involves specific software version v3.5 and various serial numbers distributed worldwide, including the United States and Canada.
The recall is due to a software issue where an unexpected Microsoft Windows Security dialog may appear during use. The user's response to this dialog may adversely affect the subsequent operation of the device.
No specific consumer instructions are provided in the source text beyond the identification of the affected units.
The recalled product
- Product
- 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…
- Manufacturer
- Volcano Corporation
- Category
- Medical Device — Imaging System
- Affected units
- 1,166
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Version v3.5 software
Distribution
Distributed nationwide across the United States.
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