BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0553-2025 · Initiated October 9, 2024

    Recall

    Recall Number
    Z-0553-2025
    Event Number
    95632
    FEI Number
    3010607747
    Product Code
    KIE
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 9, 2024
    Posted
    November 26, 2024
    Address
    Shimadzu Corp. Analytical & Measuring Instruments Div. 1 Chome 1 Nishinokyokuwabara-Cho; Nakagyo; Hon-Machi; Higashiyama Kyoto 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.

    Action

    On 10/9/24, field safety notices were mailed to customers asking them to do the following: (1) From the front and the right sides, check to see if there is any condensation water leakage. (2) If any condensation water leakage is found in the inspection, install Dew Tray Replace Kit (S228-61501-41). (3) Regardless of the checking result, attach the Main PCB Protective Sponge (S228-69971-41) For questions, please call 800-477-1227 between the hours of 8:30-5:00 EST or visit www.ssi.shimadzu.com.

    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