Class II

Medical Device Recall: Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL

Shimadzu Corp. Analytical & Measuring Instruments Div. · October 9, 2024

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

48

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0554-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.