Shimadzu Corporation Analytical&measuring Instruments Div.
Kyoto, JP
SHIMADZU CORPORATION ANALYTICAL&MEASURING INSTRUMENTS DIV. appears in FDA device records in Kyoto, JP. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Shimadzu Corporation Analytical&measuring Instruments Div. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Shimadzu Corp. Analytical & Measuring Instruments Div.enforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010607747 | 3010607747 | SHIMADZU CORPORATION ANALYTICAL&MEASURING INSTRUMENTS DIV. | 1, NISHINOKYO-KUWABARACHO, KYOTO 604-8511 JP | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0554-2025 | Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL | 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. | Class II | Open, Classified | |
| Z-0553-2025 | Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain