Reported Dec 6, 2017 · Terminated
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System…
Volcano Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corporation · 2870 Kilgore Rd · Rancho Cordova, CA · 95670-6133
Is this the product you have?
8 of 8 products
| Model / number | Product as published |
|---|---|
807400001 | Volcano Imaging System s5i |
400-0100.01 | CORE Mobile Imaging System (120V) |
400-0100.01-R | CORE Mobile Imaging System Refurbished |
400-0100.07 | CORE Mobile Imaging System (240V) |
400-0100.07-R | CORE Mobile Imaging System Refurbished |
400-0100.08 | CORE Mobile Imaging System (100V) |
400-0100.08-R | CORE Mobile Imaging System Refurbished |
400-0100.02 | CORE Imaging System For intravascular ultrasound imaging. |
- Lot codes and dates
- Version v3.5 software; Serial Numbers -Serial Number
735 of 735 codes
121020092284103020086507121070065001103070097001103070103001103020087167121070003001103020092291121020089611103020086243103020096244103070057001121020091839121020093104103020087187103060028001103060031001103060046001103060062001121000504001103070035001121020084117103020086808103070010001103070131001121020088317121020095839103020085911103020085961103020086037103020086161103020088008103020097146121020086872121020091918103020084248103020084403103020084446121020084118121020094522121020083765121020089513103020091063103020088002121020088313121020088314121020088315121020088001103020083854103000596001103000597001103020084875103020095013103060404001103070029001121020084415121020088469121070056001121070057001121070046001
431 of 431 codes
102500741001103070092001103070113001122770043001103020092873103020089435103060461001103020091108103070007001122770049001103070119001103070132001103070136001103020083918103020084476103020085910103020089434103020090528103020091106103020094498103060460001103060462001122700064001103070134001103020087013122770076001122720094899103060087001103020093397122770052001122720086557122720094161122760361001122700322001103020088495103070056001103070085001122770051001122720084537103020084668103020090805122720092269122770035001103070087001103070046001103070123001122720090351103020083940103020094465103060006001103000011001103020092279122720093378122720084536122720087061103020085110103070108001103070124001103020086806122700296001
- Version v3.5 software; Serial Numbers -
- Amount recalled
- 1166 Units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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