Recall Z-0189-2018
Volcano Corporation · initiated November 3, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
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.
FDA-determined cause: Software design
Action taken
Beginning the week of November 7, 2017, all affected US customers will be sent a field correction notification letter along with a Technical Service Bulletin (TSB) to explain how to assure the misconfiguration does not affect their system performance. For Distribution outside the US, the same letter and TSB will be sent to the initial consignee and they will execute the delivery of the Field Correction Notice and will inform the Recalling firm of the responses.
Details
- Recall number
- Z-0189-2018
- Initiated
- November 3, 2017
- Terminated
- October 20, 2023
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Quantity
- 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,
- Recalling firm
- Volcano Corporation, Rancho Cordova, CA