Device recall
Z-2668-2016: TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System…
FDA device recall · Class II · Vision RT Ltd
Key facts
| Recall number (Z-number) | Z-2668-2016 |
|---|---|
| Recall event | 74607 |
| Product | TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults… |
| Product code | IYE |
| Recalling firm | Vision RT Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 20, 2017 |
| 510(k) numbers | K140528 |
| FEI number | 3004832819 |
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