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.
FDA Recall Z-0189-2018 · Posted None
Recalling FirmVolcano Corporation
Recall StatusTerminated
Product CodeOBJ
Date Initiated2017-11-03
Date Terminated2023-10-20
Product Quantity1166 Units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.