Device recall
Z-1309-2016: MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and…
FDA device recall · Class II · Viewray Incorporated
Key facts
| Recall number (Z-number) | Z-1309-2016 |
|---|---|
| Recall event | 73550 |
| Product | MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated |
| Product code | IYE |
| Recalling firm | Viewray Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 22, 2017 |
| 510(k) numbers | K111862 |
| FEI number | 3007546534 |
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