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Shimadzu Corporation Analytical&Measuring Instruments Div.

Country not established FDA establishment FEI 3010607747

Devices
0
Registrations
FDA
FDA recalls
22 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3010607747
Address
1, NISHINOKYO-KUWABARACHO, KYOTO

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

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. Distribution: Worldwide - US Nationwide distribution in the states of MS, AR, TX, CA, MA, MI, FL, OK, WI, IN, MN, OH, NJ, NY, IL, KY,…
      Full distribution text Worldwide - US Nationwide distribution in the states of MS, AR, TX, CA, MA, MI, FL, OK, WI, IN, MN, OH, NJ, NY, IL, KY, NV, HI, SD, ID, MI, UT, WA, MO, VA, GA and the countries of DE, CN, JP, UY.
    • 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. Distribution: Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.

This is an FDA establishment record without devices in deviCERTS.