Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL recallZ-0554-2025 · Shimadzu Corp. Analytical & Measuring Instruments Div. · initiated Oct 9, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Shimadzu Corp. Analytical & Measuring Instruments Div. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0554-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 9, 2024
- Posted by the FDA
- Nov 26, 2024
- Recalling firm
- Shimadzu Corp. Analytical & Measuring Instruments Div.
- Quantity
- 48
- Product code
- KIE
- Distribution
- Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.
Product description
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Model/UDI-DI/Serial Numbers: SIL-40C XR CL/04540217420582/L2C316051002, L2C316051003, L2C316051004, L2C316051005, L2C316051006, L2C316051007, L2C316151012, L2C316151013, L2C316151014, L2C316151015. SIL-40C X3 CL/04540217420575/L2C305850001, L2C305950002, L2C306151025, L2C306051001, L2C306051002, L2C306051003, L2C306051004, L2C306051005, L2C306051007, L2C306051006, L2C306051008, L2C306051009, L2C306051010, L2C306051011, L2C306051012, L2C306051013, L2C306051014, L2C306051015, L2C306151017, L2C306151018, L2C306151022, L2C306151023, L2C306151024, L2C306151026, L2C306151028, L2C306151027, L2C306151029, L2C306151030, L2C306151031, L2C306151032, L2C306151033, L2C306151034, L2C306151035, L2C306151036, L2C306151037, L2C306151038, L2C306151040, L2C306151039. Firmware versions below 1.16.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- SIL-40C X3 CL 228-65120-55Shimadzu Corporation · Apparatus, High Pressure Liquid Chromatography1 recall0 reports
- SIL-40C XR CL 228-65103-55Shimadzu Corporation · Apparatus, High Pressure Liquid Chromatography1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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