BEUDAMED
    FDA Enforcement Class II Ongoing

    Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL

    Recall: Z-0554-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0554-2025
    Event ID
    95633
    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-40C XR CL, SIL-40C X3 CL

    Reason

    There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of patient sample testing.

    Code Info

    Model/UDI-DI/Serial Numbers: SIL-40C XR CL/04540217420582/L2C316051002, L2C316051003, L2C316051004, L2C316051005, L2C316051006, L2C316051007, L2C316151012, L2C316151013, L2C316151014, L2C316151015. SIL-40C X3 CL/04540217420575/L2C305850001, L2C305950002, L2C306151025, L2C306051001, L2C306051002, L2C306051003, L2C306051004, L2C306051005, L2C306051007, L2C306051006, L2C306051008, L2C306051009, L2C306051010, L2C306051011, L2C306051012, L2C306051013, L2C306051014, L2C306051015, L2C306151017, L2C306151018, L2C306151022, L2C306151023, L2C306151024, L2C306151026, L2C306151028, L2C306151027, L2C306151029, L2C306151030, L2C306151031, L2C306151032, L2C306151033, L2C306151034, L2C306151035, L2C306151036, L2C306151037, L2C306151038, L2C306151040, L2C306151039. Firmware versions below 1.16.

    Distribution

    Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.

    Quantity

    48