Shimadzu Corp. Analytical & Measuring Instruments Div. Recall 95633
Description: Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Shimadzu Corp. Analytical & Measuring Instruments Div. Recall 95633 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0554-2025 |
| Event ID | 95633 |
| Event Description | Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE. |
| Quantity | 48 |
| Recall 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. |
| Device Classification | 20241204 |
| Device Code Info | 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. |
| Center Classification Date | 20241126 |
| Recall Initiation Date | 20241009 |
| Recalling Firm | Shimadzu Corp. Analytical & Measuring Instruments Div. |
| Initial Notification | Letter |
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