Recall Z-0553-2025— Shimadzu Corp. Analytical & Measuring Instruments Div.
Class II · Ongoing
Class II FDA medical device recall by Shimadzu Corp. Analytical & Measuring Instruments Div., initiated 2024-10-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL. 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..
- Recalling firm
- Shimadzu Corp. Analytical & Measuring Instruments Div.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-09
- Firm location
- Kyoto, Japan
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.