Shimadzu Corp. Analytical & Measuring Instruments Div.: Medical Device Recall in 2024 - (Recall #: Z-0554-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 9, 2024

Date Posted: December 4, 2024

Recall Number: Z-0554-2025

Event ID: 95633

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.

Status: Ongoing

Product Quantity: 48

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated