Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL

FDA device recall Z-0554-2025 · 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 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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

KIE

Quantity affected

48

Distribution

Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.

Date initiated

2024-10-09

Date posted

2024-11-26

Location

Kyoto, 1 Chome, Japan