FDA-Device2024-12-04Class II
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Shimadzu Corp. Analytical & Measuring Instruments Div.
Hazard
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.
Sold states
Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.
Affected count
48
Manufactured in
1 Chome 1, Nishinokyokuwabara-Cho; Nakagyo; Hon-Machi; Higashiyama, Kyoto, Japan
Products
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0554-2025Don't want to check this manually?
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