Device recall
Z-0934-2015: AlignRT is a video-based three-dimensional (3D) surface imaging system which is…
FDA device recall · Class II · Vision Rt Inc
Key facts
| Recall number (Z-number) | Z-0934-2015 |
|---|---|
| Recall event | 70009 |
| Product | AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. |
| Product code | IYE |
| Recalling firm | Vision Rt Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2016 |
| 510(k) numbers | K052682 |
| 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