Shimadzu Corp. Analytical & Measuring Instruments Div.: Device Recall

Recall #Z-0554-2025 · 10/09/2024

Class II: Risk

Recall Details

Recall Number: Z-0554-2025
Classification: Class II
Product Type: Device
Recalling Firm: Shimadzu Corp. Analytical & Measuring Instruments Div.
Status: Ongoing
Date Initiated: 10/09/2024
Location: Kyoto, Japan
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 48

Reason for Recall

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.

Product Description

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

Distribution Pattern

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

Other Recalls by Shimadzu Corp. Analytical & Measuring Instruments Div.

Class II: Risk 10/09/2024

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.

View all recalls by Shimadzu Corp. Analytical & Measuring Instruments Div. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.