BEUDAMED
    FDA Enforcement Class II Ongoing

    SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

    Recall: Z-0885-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0885-2022
    Event ID
    89673
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Volcano Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    January 19, 2022
    Classification Date
    April 6, 2022
    Address
    2451 Mercantile Dr, Rancho Cordova, CA, 95742-6326, United States

    Description

    SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

    Reason

    If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.

    Code Info

    All serial numbers, limited to cases when: The SyncVision runs the current supported software version 4.2.x, AND The secondary modality (IntraSight IVUS) runs software version 5.x. Device Identifier (DI): 00845225012434

    Distribution

    US: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX, NC, OH, WA, OR, NM, MT, IA, MI, TN, MN, PA, AL, MA, WV, NV, NH, CT, NE, NJ, HI, AR, UT, MD, SC, MS, AK, DE OUS: JP, SA, GB, DE, PT, SG, PL, ZA, NL, MT, ES, IN, GR, EG, FI, HK, FR, NO, DK, BE, AT, IT, CO, KW, MX, PS, QA, CY, CA, TW, LV, SE, HR, SI, MY, KR, IL, TH, AU, BR, CL, SK, CH, LB, OM, ID, PK, IE, NZ, PR, RO, MM, AR, RS, RU, PA, KE, UZ

    Quantity

    3,216