BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0554-2025 · Initiated October 9, 2024

    Recall

    Recall Number
    Z-0554-2025
    Event Number
    95633
    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-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.

    Action

    On 10/9/24, field safety notices were mailed to customers asking them to do the following: Check the Serial Numbers, and if the instruments are affected by this issue, contact your regional office. The corrective actions to be taken to affective products are (1) Add a cover part to the main board. (2) Update the SIL-40 firmware to Ver. 1.16 or above. 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 DE, PA and the country of DE.

    Quantity

    48