Medical device recalls Moderate risk

Autosampler recalled over fire hazard

Recall date
October 9, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Shimadzu Corp. Analytical & Measuring Instruments Div. recalls Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Recall number
Z-0554-2025
FDA classification
Class II
Brand / firm
Shimadzu Corp. Analytical & Measuring Instruments Div.
Sold / distributed
Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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