BEUDAMED
    FDA Enforcement Class II Ongoing

    Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

    Recall: Z-0553-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0553-2025
    Event ID
    95632
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Shimadzu Corp. Analytical & Measuring Instruments Div.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 9, 2024
    Classification Date
    November 26, 2024
    Address
    1 Chome 1, Nishinokyokuwabara-Cho; Nakagyo; Hon-Machi; Higashiyama, Kyoto, N/A, Japan

    Description

    Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

    Reason

    There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.

    Code Info

    Model/UDI-DI/Serial Number: SIL-20ACXR CL/04540217420131/L20995250001, L20995250002, L20995250003, L20995250004, L20995250005, L20995250006, L20995250007, L20995250008, L20995350010, L20995350011, L20995350012, L20995350013, L20995350014, L20995350015, L20995450016, L20995450017, L20995450018, L20995450019, L20995450020, L20995450021, L20995450022, L20995450023, L20995450024, L20995450025, L20995450026, L20995550027, L20995550028, L20995550029, L20995550030, L20995650031, L20995650032, L20995650033, L20995650034, L20995650035, L20995650036, L20995650037, L20995650038, L20995650039, L20995650040, L20995650041, L20995650042, L20995650043, L20995650044, L20995650045, L20995650046, L20995560001, L20995660002, L20995660003, L20995660004, L20995660005, L20995660006, L20995660007, L20995660008, L20995660009, L20995660010, L20995660011, L20995660012, L20995660013, L20995660014, L20995660015, L20995660016, L20995660017, L20995660018, L20995660019, L20995660020, L20995660021, L20995660022, L20995660023, L20995660024, L20995660025, L20995660026, L20995660027, L20995660028, L20995660029, L20995660030, L20995660031, L20995660032, L20995660033, L20995660034, L20995660035, L20995660036, L20995660037, L20995660038, L20995660039, L20995660040, L20995660041, L20995660042, L20995660043, L20995660044, L20995660045, L20995660046, L20995660047, L20995660048, L20995660049, L20995660050, L20995660051, L20995660052, L20995660053, L20995660054, L20995660055, L20995660056, L20995660057, L20995250009, L20995270001, L20995270002, L20995270003, L20995270004, L20995270005, L20995370006, L20995370007, L20995370008, L20995370009, L20995370010, L20995370011, L20995370012, L20995370013, L20995370014, L20995370015, L20995370016, L20995370017, L20995370018, L20995370019, L20995370020, L20995370021, L20995370022, L20995370023, L20995370024, L20995370025, L20995470028, L20995770032. SIL-20ACHT CL/04540217420124/L20985350001, L20985450002, L20985750003, L20985750004. SIL-30AC CL/04540217420155/L21005250001, L21005250002, L21005250003, L21005250004, L21005250005, L21005250006, L21005250007, L21005350008, L21005350009, L21005350010, L21005350011, L21005350012, L21005350013, L21005350014, L21005350015, L21005350016, L21005350017, L21005350018, L21005350019, L21005350020, L21005350021, L21005350022, L21005350023, L21005350024, L21005450025, L21005550026, L21005550027, L21005650028, L21005650029, L21005750030, L21005750031, L21005570001, L21005570002, L21005670003, L21005670004, L21005670005, L21005670006, L21005670007, L21005670008, L21005770009, L21005770010, L21005770011, L21005770012, L21005770013, L21005770014.

    Distribution

    Worldwide - US Nationwide distribution in the states of MS, AR, TX, CA, MA, MI, FL, OK, WI, IN, MN, OH, NJ, NY, IL, KY, NV, HI, SD, ID, MI, UT, WA, MO, VA, GA and the countries of DE, CN, JP, UY.

    Quantity

    179