Recall Z-0553-2025 ยท KIE Apparatus, High Pressure Liquid Chromatography
Shimadzu Corp. Analytical & Measuring Instruments Div.
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
| Date | Nov 26, 2024 (initiated Oct 9, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.