Device recall
Z-1585-2018: MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear…
FDA device recall · Class II · Hitachi Ltd., Medical System Operations Group
Key facts
| Recall number (Z-number) | Z-1585-2018 |
|---|---|
| Recall event | 79439 |
| Product | MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. |
| Product code | IYE |
| Recalling firm | Hitachi Ltd., Medical System Operations Group |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2019 |
| 510(k) numbers | K072047, K122450, K152867 |
| FEI number | 3018423337 |
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