Device recall
Z-0676-2020: MRIdian Linac Radiation Therapy System Model 10000 and 20000
FDA device recall · Class II · Viewray, Inc.
Key facts
| Recall number (Z-number) | Z-0676-2020 |
|---|---|
| Recall event | 84303 |
| Product | MRIdian Linac Radiation Therapy System Model 10000 and 20000 |
| Product code | IYE |
| Recalling firm | Viewray, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K111862, K170751 |
| FEI number | 3011233554 |
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