Shimadzu Corporation Analytical&Measuring Instruments Div.
Country not established FDA establishment FEI 3010607747
- Devices
- 0
- Registrations
- FDA
- FDA recalls
- 22 ongoing
Company details
- FDA FEI number
- 3010607747
- Address
- 1, NISHINOKYO-KUWABARACHO, KYOTO
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 2
- 2025 0
- 2026 0
2024
- 9 Oct 2024 Z-0553-2025 Class II Ongoing There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
Full distribution text
- 9 Oct 2024 Z-0554-2025 Class II Ongoing 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.
- 9 Oct 2024 Z-0553-2025 Class II Ongoing There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.