Z-0554-2025Class II

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

Name: Z-0554-2025 Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Creator: Shimadzu Corp. Analytical & Measuring Instruments Div.
Published: 2024-10-09
License: https://open.fda.gov/license/

Shimadzu Corporation Analytical&measuring Instruments Div. / initiated 2024-10-09 / Open, Classified / root cause: design

FDA source

Shimadzu Corp. Analytical & Measuring Instruments Div. began a recall of Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL on 2024-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0554-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-09
Posted: 2024-11-26
Recalling firm: Shimadzu Corporation Analytical&measuring Instruments Div.
Product: Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Product code: KIE Apparatus, High Pressure Liquid Chromatography
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.
Root cause tag: design
FDA 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 in commerce: 48
Distribution: Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0554-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0554-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-26

Product code KIE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)