# FDA recall Z-0189-2018

> **Volcano Corporation** · Class II · device recall initiated 2017-11-03.

## 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 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.

## 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,

## Key facts

- **Recall number:** Z-0189-2018
- **Recalling firm:** Volcano Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-03
- **Report date:** 2017-12-06
- **Termination date:** 2023-10-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rancho Cordova, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0189-2018

## Citation

> AI Analytics. FDA recall Z-0189-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0189-2018. Source: US FDA. Licensed CC0.

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