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 40
Check against the official notice below — it lists the full affected range.
Volcano Corporation is recalling 1,166 units of its Volcano Imaging System s5i, CORE Mobile Imaging System (120V), and CORE Mobile Imaging System Refurbished devices worldwide, including in the US and Canada. The recalled devices run version v3.5 software and are identified by specific serial numbers. The hazard involves an unexpected Microsoft Windows Security dialog that may appear during device use, and a user's response to this dialog could negatively affect how the device operates afterward.
The recall record does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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, Quantity: 1166 Units Lot/code info: 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 103020092827 121020085705 121020093100 121020091471 103070069001 103020087956 121020084507 103020084133 121070001001 121070058001 103020090806 103020091107 103020088815 103070114001 103070115001 103070140001 103070141001 103020088818 103070148001 103070149001 121020084123 121020084124 121020088216 121020089333 121020095380 103020092277 103020092335 103020092385 103020091752 103020094264 103020096245 103020098272 121020090883 121020095394 121020083335 121020095451 103020089017 103020091348 103020092638 121020091914 121060315001 121060316001 103020092278 103020083301 1030
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.