Company:Volcano Corp.
Date of Enforcement Report 12/6/2017
Class lI:
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.
Recall Number Z-0189-2018
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/MANUFACTURER
Volcano Corp., Rancho Cordova, CA on 11/3/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1166 Units
DISTRIBUTION
Nationwide and Internationally
___________________________________
