Shimadzu Medical Systems Usa Com
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1039-2019 | Class II | SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is i | January 14, 2019 |
| Z-0959-2019 | Class II | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for | January 14, 2019 |
| Z-0864-2019 | Class II | TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular a | January 14, 2019 |
| Z-0197-2019 | Class II | TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angio | June 15, 2018 |
| Z-2655-2017 | Class II | SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking gen | May 23, 2017 |
| Z-2654-2017 | Class II | SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system | May 23, 2017 |
| Z-2653-2017 | Class II | SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-r | May 23, 2017 |