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MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1308-2016 | Class II | VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 L | March 7, 2016 |
| Z-1244-2016 | Class II | MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation ther | December 15, 2015 |
| Z-1574-2015 | Class II | MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) | April 17, 2015 |
| Z-0821-2015 | Class II | VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version | December 2, 2014 |
| Z-2653-2014 | Class II | VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. | July 5, 2014 |
| Z-1931-2013 | Class II | MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary an | June 21, 2013 |