# FDA recall Z-0554-2025

> **Shimadzu Corp. Analytical & Measuring Instruments Div.** · Class II · device recall initiated 2024-10-09.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0554-2025
- **Recalling firm:** Shimadzu Corp. Analytical & Measuring Instruments Div.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-09
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kyoto, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0554-2025

## Citation

> AI Analytics. FDA recall Z-0554-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0554-2025. Source: US FDA. Licensed CC0.

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