BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0189-2018 · Initiated November 3, 2017

    Recall

    Recall Number
    Z-0189-2018
    Event Number
    78569
    Firm
    Volcano Corporation
    FEI Number
    2939520
    Product Code
    OBJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 3, 2017
    Terminated
    October 20, 2023
    Address
    2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133

    Description

    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.

    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.

    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.

    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