Recall Z-0554-2025 ยท KIE Apparatus, High Pressure Liquid Chromatography
Shimadzu Corp. Analytical & Measuring Instruments Div.
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 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 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. |
| Root cause | Device Design |
| Action | On 10/9/24, field safety notices were mailed to customers asking them to do the following: Check the Serial Numbers, and if the instruments are affected by this issue, contact your regional office. The corrective actions to be taken to affective products are (1) Add a cover part to the main board. (2) Update the SIL-40 firmware to Ver. 1.16 or above. For questions, please call 800-477-1227 between the hours of 8:30-5:00 EST or visit www.ssi.shimadzu.com. |
| Quantity | 48 |
| Distribution | Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.