FDA Device recall Z-0189-2018
Volcano Imaging System s5i REF 807400001
- FDA Device
- Class II
- terminated
- Published 2017-12-06
On 2017-12-06 the FDA classified a Class II recall of Volcano Imaging System s5i REF 807400001 by Volcano, citing 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 operat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0189-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-03 |
| Published | 2017-12-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Volcano |
| Distribution | US |
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.
Identifiers
| code_info | Version v3.5 software; Serial Numbers - 121020092284 103020086507 121070065001 103070097001 103070103001 103020087…Version v3.5 software; Serial Numbers - 121020092284 103020086507 121070065001 103070097001 103070103001 103020087167 121070003001 103020092291 121020089611 103020086243 103020096244 103070057001 121020091839 121020093104 103020087187 103060028001 103060031001 103060046001 103060062001 121000504001 103070035001 121020084117 103020086808 103070010001 103070131001 121020088317 121020095839 103020085911 103020085961 103020086037 103020086161 103020088008 103020097146 121020086872 121020091918 103020084248 103020084403 103020084446 121020084118 121020094522 121020083765 121020089513 103020091063 103020088002 121020088313 121020088314 121020088315 121020088001 103020083854 103000596001 103000597001 103020084875 103020095013 103060404001 103070029001 121020084415 121020088469 121070056001 121070057001 121070046001 103020083200 121020089671 103070036001 103070037001 121070041001 121070042001 121020083595 121020084767 10302009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0189-2018%22
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