Recall Z-0189-2018— Volcano Corporation
Class II · Terminated
Class II FDA medical device recall by Volcano Corporation, initiated 2017-11-03, terminated 2023-10-20. It names 2 FDA 510(k) clearances: K123898, K071554. 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 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.. Reason: 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..
- Recalling firm
- Volcano Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-03
- Terminated
- 2023-10-20
- Firm location
- Rancho Cordova, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K123898 — VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
- K071554 — VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.