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

FDA device recall Z-0553-2025 · posted 2024-11-26 · Open, Classified

Recall details

Recalling firm

Shimadzu Corp. Analytical & Measuring Instruments Div.

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.

Action taken

On 10/9/24, field safety notices were mailed to customers asking them to do the following: (1) From the front and the right sides, check to see if there is any condensation water leakage. (2) If any condensation water leakage is found in the inspection, install Dew Tray Replace Kit (S228-61501-41). (3) Regardless of the checking result, attach the Main PCB Protective Sponge (S228-69971-41) For questions, please call 800-477-1227 between the hours of 8:30-5:00 EST or visit www.ssi.shimadzu.com.

Root cause

Device Design

Status

Open, Classified

Product code

KIE

Quantity affected

179

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.

Date initiated

2024-10-09

Date posted

2024-11-26

Location

Kyoto, 1 Chome, Japan