FDA recall Z-0553-2025

Shimadzu Corp. Analytical & Measuring Instruments Div. · Class II · device

Product

Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

Reason for recall

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.

Distribution

Worldwide - US Nationwide distribution in the states of MS, AR, TX, CA, MA, MI, FL, OK, WI, IN, MN, OH, NJ, NY, IL, KY, NV, HI, SD, ID, MI, UT, WA, MO, VA, GA and the countries of DE, CN, JP, UY.

Key facts

Status
Ongoing
Initiation date
2024-10-09
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kyoto, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0553-2025