BEUDAMED
    FDA Enforcement Class III Ongoing

    MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

    Recall: Z-0917-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0917-2022
    Event ID
    89698
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Volcano Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    February 3, 2022
    Classification Date
    April 12, 2022
    Address
    3721 Valley Centre Dr Ste 500, N/A, San Diego, CA, 92130-3328, United States

    Description

    MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

    Reason

    Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.

    Code Info

    MM-TSMs with bottom protective beams

    Distribution

    US: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO, KY, LA, DE, MA, MT, MO, VA, AL, NY, WV, SC, IN, GA, IA, OH, UT, NH, MS, TN, OK, ID, MD, HI, RI, WY, DC, WA, KS, NE, ND, CT, VT. OUS: SK, IT, DK, GB, DE, SE, IN, KW, QA, PL, NL, CL, JP, BE, AU, FR, PF, PT, NZ, CA, ES, PK, CY, AT, IL, IE, CH, GR, SA, PS, LB, HK, IS, TH, AR, OM, AE, NO, ID, RO, RS, MM, ZA, SG

    Quantity

    1358