Device recall
Z-1244-2016: MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended…
FDA device recall · Class II · MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Key facts
| Recall number (Z-number) | Z-1244-2016 |
|---|---|
| Recall event | 72991 |
| Product | MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated. |
| Product code | IYE |
| Recalling firm | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 20, 2017 |
| 510(k) numbers | K072047, K122450, K152867 |
| 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