Device recall
Z-0464-2015: AlignRT- Intended for prescription use. The system is indicated for use during…
FDA device recall · Class II · Vision Rt Inc
Key facts
| Recall number (Z-number) | Z-0464-2015 |
|---|---|
| Recall event | 69515 |
| Product | AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. |
| Product code | IYE |
| Recalling firm | Vision Rt Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2016 |
| 510(k) numbers | K123371 |
| FEI number | 3017888782 |
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