FDA Device recall Z-0554-2025
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL by Shimadzu Analytical And Measuring Instruments Div, citing 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 on….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0554-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-09 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Shimadzu Analytical And Measuring Instruments Div |
| Distribution | US |
Product
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
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.
Identifiers
| code_info | Model/UDI-DI/Serial Numbers: SIL-40C XR CL/04540217420582/L2C316051002, L2C316051003, L2C316051004, L2C316051005, L2C31…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0554-2025%22
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