Kyoto, Japan
Shimadzu Corp. Analytical & Measuring Instruments Div. recalls
2 recalls recorded since 2018, most recently on 9 October 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 October 2024
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of DE, PA and the country of DE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0554-2025
- Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Ongoing Class II Medical devices
- Recall started
- 9 October 2024
- Reason
- 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, NV, HI, SD, ID, MI, UT, WA, MO, VA, GA and the countries of DE, CN, JP, UY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0553-2025
- Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.