SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDA Record
- Latest inspection NAI · Aug 1, 2013
- No warning letters matched by name
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 6 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION" is on file.
- Latest recall
- Z-0499-2026 · Class II · Oct 16, 2025
- Latest inspection
- Aug 1, 2013 · NAI
- Latest 510(k)
- May 24, 2024
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 6 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION: FDA recall records per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 1 | 0 |
| 2024 | 0 | 0 | 0 | 4 | 0 |
| 2023 | 0 | 0 | 0 | 1 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0499-2026 | Class II | Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and… | Oct 16, 2025 |
| Z-0316-2025 | Class II | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and… | Sep 6, 2024 |
| Z-0317-2025 | Class II | The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and… | Sep 6, 2024 |
| Z-0139-2025 | Class II | Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system… | Sep 6, 2024 |
| Z-1292-2024 | Class II | Shimadzu, Trinias, Digital Angiography System | Jan 29, 2024 |
| Z-2270-2023 | Class II | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision… | Apr 10, 2023 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 1, 2013 | Kyoto, Japan | Devices | No Action Indicated (NAI) | 3002808139 |
| Sep 9, 2011 | Kyoto, Japan | Devices | No Action Indicated (NAI) | 3002808139 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002808139 | Kyoto, Japan | 2 | Aug 1, 2013 |
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION and the FDA: common questions
Has SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION received an FDA warning letter?
No FDA warning letter addressed to the name "SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION received an FDA Form 483?
FDA has not published a Form 483 for "SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION?
The most recent FDA inspection on file ended Aug 1, 2013 at Kyoto, Japan and was classified NAI. FDA has 2 inspections of SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION on file.
Has SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION had an FDA recall?
Yes. SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION has 6 FDA recalls on record. The most recent started Oct 16, 2025.
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