SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDA Inspection Record
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION is an FDA-registered facility (FEI 3002808139) located in KYOTO Ky?to, JP. RegDataLab tracks 2 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Aug 1, 2013: No Action Indicated (NAI)
- Inspections on record
- 2 (2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 6, latest Oct 16, 2025
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 1, 2013 | No Action Indicated (NAI) | No citations listed |
| Sep 9, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Oct 16, 2025 | Class II | Z-0499-2026 | Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M
used with RADspeed… Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly… |
| Sep 30, 2025 | Class II | Z-0347-2027 | Trinias Opera Smart (C16s, F12s)/Opera Grand(C12s,C16s, F12s)/Smart OBL Interventional… The mounting bolts securing the C-arm drive unit of the X-ray system may not be torqued to specification, potentially compromising… |
| Sep 6, 2024 | Class II | Z-0139-2025 | Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This… If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and… |
| Sep 6, 2024 | Class II | Z-0316-2025 | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for… and 1 more product X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy… |
| Jan 29, 2024 | Class II | Z-1292-2024 | Shimadzu, Trinias, Digital Angiography System Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function. |
| Apr 10, 2023 | Class II | Z-2270-2023 | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO… Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable… |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Location
- KYOTO Ky?to (JP)
- Source
- device