SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION appears in FDA public data with 6 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0499-2026, Class II) was initiated on October 16, 2025. Its most recent 510(k) clearance was granted on May 24, 2024.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
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 FLUO | October 16, 2025 |
| Z-0317-2025 | Class II | The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and | September 6, 2024 |
| Z-0139-2025 | Class II | Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system cons | September 6, 2024 |
| Z-0316-2025 | Class II | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and | September 6, 2024 |
| Z-1292-2024 | Class II | Shimadzu, Trinias, Digital Angiography System | January 29, 2024 |
| Z-2270-2023 | Class II | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision | April 10, 2023 |