Recall Z-0189-2018 ยท OBJ Catheter, Ultrasound, Intravascular
Volcano Corporation
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 400-010
| Date | Nov 3, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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. |
| 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, |
| FDA record | Open on fda.gov |