PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 6, 2017 Initiated: November 3, 2017 #Z-0189-2018

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.

Details

Recalling Firm
Volcano Corporation
Units Affected
1166 Units
Distribution
Worldwide distribution including US nationwide and Canada, AE, AT, AU, BD, BE, BG, BR, CH, CL, CN, CY, DE, DK, EG, ES, FR, GB, HU, IE, IL, IN, IT, JO, JP, KW, KR, LB, MA, MX, MY, NL, NO, PA, PK, PL, PT, QA, RO, RU, SA, SE, SG, SK, Sri Lanka, TH, TW, UAE, UK, ZA,
Location
Rancho Cordova, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Volcano Corporation. Units affected: 1166 Units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2017. Severity: Moderate. Recall number: Z-0189-2018.

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