Recall Z-0554-2025— 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-40C XR CL, SIL-40C X3 CL. Reason: 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..
- 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-40C XR CL, SIL-40C X3 CL
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.