Device recall
Z-1931-2013: MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or…
FDA device recall · Class II · MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Key facts
| Recall number (Z-number) | Z-1931-2013 |
|---|---|
| Recall event | 65786 |
| Product | MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the… |
| Product code | IYE |
| Recalling firm | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2017 |
| 510(k) numbers | K072047, K122450 |
| FEI number | 3006942329 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database